Identity
- Device Name
- Hair transplant guide device EUDAMED
- Model / Reference
- ODSI-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800181200174 EUDAMED
- Basic UDI-DI
- B-08800181200174 EUDAMED
- EMDN Code
- K01020114 MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
Hair transplant guide device by OHDAE Corporation — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800181200174 | 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 29af3ede-e64b-455b-b791-90cfd149d693 61 fields · synced Jun 18, 2026