Identity
- Trade Name
- FUE Punch Needle EUDAMED
- Device Name
- FUE PUNCH NEEDLE EUDAMED
- Model / Reference
- ODSI-10A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800181200471 EUDAMED
- Basic UDI-DI
- 0880018120047SR EUDAMED
- Direct Marketing DI
- 08800181200471 EUDAMED
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Category: Surgical retractor/retraction system blade, single-use
FUE Punch Needle by OHDAE Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical retractor/retraction system blade, single-use.
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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 | 0880018120047SR | Class I | Active |
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Manufacturer
- Manufacturer
- OHDAE Corporation
- EUDAMED SRN
- KR-MF-000025038
- Authorised Representative
- AeMi World e.K DE-AR-000007704
Sources (1)
- EUDAMED 6574f29a-0073-47b2-856a-3b976035da80 61 fields · synced Jun 19, 2026