ACRO BIOMEDICAL CO., LTD.

Unified Business No.

54562029

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

2F & 3F, No. 57, Luke 2nd Rd., Luzhu Dist., Kaohsiung City 821011, Taiwan (R.O.C.)↗
Kaohsiung City (7,253) · Luzhu Dist. (462)

Listing

Emerging stock (TPEx) (359) 6748

Organisation type

Company Limited by Shares

Founded

2014-06-26

Paid-in capital

NT$ 712,181,980

Representative

Hsieh Ta-jen

Phone

07-6955569

Website

https://www.acrobiomedical.com/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M

Ownership

Group subsidiary / corporate-held · Kai Erh Chin Biotechnology Co., Ltd.

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since 2020-01 (6 yrs); last handover 2020-01

Growth & profitability

Revenue 2026-09 YoY +1201.5%, year-to-date +233.7%
Gross margin 68.5%, operating margin -169.2%, net margin -144.6% (2026-Q2 YTD)

Compliance record

Labour Standards Act penalties: 2 case(s) in 5 years, latest 2026-01-22, fines NT$ 60,000 (Art. 38; Art. 19) — matched by company name

Certifications 39

• Medical device license (Class I) (1,430)Official registry Valid until 2023-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-08-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-08-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-08-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-08-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-01-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-01-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-01-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-01-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-04-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-02-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-03-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-03-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-07-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-08-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-01-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-11-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-10-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-01-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-08-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-06-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-11-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2030-08-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2029-04-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2029-04-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2031-05-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2029-04-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2029-04-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2029-04-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2030-03-11 · Taiwan Food and Drug Administration (TFDA)
• FDA (53)Self-reported
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported

Processes & materials 2

• Copper alloy (324) · MetalSelf-reported
• Forging (299) · FormingSelf-reported

Patents 3

• 2023 Use of collagen particles in promoting hair follicle formation or angiogenesis
• 2020 Decellularized organ and preparation method thereof
• 2020 Decellularized bone graft and artificial graft assembly comprising same

North American market evidence 5

• FDA 510(k) clearance K233378 2024-10-18
  ABCcolla® Collagen ADM Scaffold
• FDA 510(k) clearance K212156 2021-10-08
  ABCcolla Bone Matrix
• FDA 510(k) clearance K171629 2018-02-01
  ABCcolla Bone Graft
• FDA 510(k) clearance K162348 2017-05-10
  ABCcolla Collagen Matrix
• FDA medical device registration 3014982332 2018-11-26 – 2024-11-05
  Filler, Bone Void, Calcium Compound; Wound Dressing With Animal-Derived Material(S); Elastomer, Silicone, For Scar Management and more (4)

Government programs & awards 1

• SBIR (Small Business Innovation Research) program 2023 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

Recent changes 4

• 2026-10-31
  Certification expiryMedical device license (Class I) certificate expired on 2026-10-31
• 2026-08-10
  Certification expiryMedical device license (Class I) certificate expired on 2026-08-10
• 2026-01-22
  PenaltiesLabour Standards Act penalties: latest case 2026-01-22; 2 case(s) in 5 years, fines NT$ 60,000
• 2026-01-21
  Certification expiryMedical device license (Class I) certificate expired on 2026-01-21

RSS feed · Recent changes at Taiwanese manufacturers →

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