Identity
- Trade Name
- ONETRAC™ EUDAMED
- Device Name
- ONETRAC™ Retractor EUDAMED
- Model / Reference
- C100110 EUDAMEDC100170 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850040140095 EUDAMED
- Basic UDI-DI
- 0850040140C10Q6 EUDAMED
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Onetrac™ by OBP Medical Corporation DBA OBP Medical — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850040140C10Q6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- OBP Medical Corporation DBA OBP Medical
- EUDAMED SRN
- US-MF-000033317
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 52451344-ea44-4cd7-b29e-6849bb4ca41a 61 fields · synced Oct 6, 2026