Bio Protech Inc.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000012687
Bio Protech Inc. is a medical device manufacturer based in South Korea, with 165 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class IIb, I and IIa; FDA Class II) as of 15 Nov 2026.
- Devices
- 165
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 149
- FDA GUDID 18
- FDA 510(k) 17
- Device classes
- EU Class IIb 84
- EU Class I 46
- EU Class IIa 18
- FDA Class II 17
- Top EMDN categories
- Sites and related companies
- Meridius Medical Europe Limited authorised representative
- Identifiers
- EUDAMED SRN KR-MF-000012687
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
- Authorised rep.
- Meridius Medical Europe LimitedIE
What Bio Protech Inc. makes
Bio Pro Tech Inc. manufactures single-use electrocardiographic electrodes, including EMG needle electrodes, concentric and monopolar needle electrodes, and neonatal ECG electrodes. Their product line also includes disposable hypodermic and EP needle electrodes, ECG tabb electrodes, and electrodes for electrosurgical units (ESU).
The company’s devices are classified as Class I or Class II/IIa under medical device regulations, with listings in the EU’s eudamed database and the FDA’s 510(k) registry. The company is based in South Korea.
Catalogue
Search and filter all 165 devicesShowing 1-50 of 165
Company details
- EUDAMED SRN
- KR-MF-000012687
- EUDAMED status
- Active
- EUDAMED registered name
- BIO PROTECH INC.
- EUDAMED abbreviated name
- BIO PROTECH
- Registered address
- 151-3, Donghwagongdan-ro, 26365, Wonju-si, Gangwon-do, South Korea
- Website
- www.protechsite.com
- jnh@protechsite.com
- Phone
- +82337357720
- PRRC contact
- Peter Seok
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 15 Oct 2030
DNV Product Assurance AS 2460 1 certificate
- C611944 Active
Quality management system EU MDR
- Issued
- 15 Oct 2025
- Expires
- 15 Oct 2030
FDA establishments
- Bioprotech Inc. US
Frequently asked questions
How many devices does BIO PROTECH INC. have in the registry?
The registry currently lists 165 devices for BIO PROTECH INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list BIO PROTECH INC.'s devices?
Among its 50 most recently registered devices, BIO PROTECH INC. has devices listed in EUDAMED (50 devices).
What risk classes do BIO PROTECH INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for BIO PROTECH INC.'s devices are Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for BIO PROTECH INC.?
EUDAMED lists 1 certificate for BIO PROTECH INC. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 15 Oct 2025.
What are the newest devices from BIO PROTECH INC. in the registry?
The most recently registered devices listed for BIO PROTECH INC. include e-LECTRO PLATE and PROPLATE.
Which FDA establishments are linked to BIO PROTECH INC.?
1 FDA establishment is linked to BIO PROTECH INC. in the registry; they are listed on the company page.