Identity
- Trade Name
- Inksafe EUDAMED
- Device Name
- Wooden Tongue Depressors EUDAMED
- Model / Reference
- JF0850 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50605064674430 EUDAMED
- Basic UDI-DI
- 506050646JF0114PD EUDAMED
- EMDN Code
- V9001 TONGUE DEPRESSORS, 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
Inksafe by JFA Medical Ltd. — Class I — 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 | 506050646JF0114PD | Class I | Active |
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Manufacturer
- Manufacturer
- JFA Medical Ltd.
- EUDAMED SRN
- GB-MF-000021252
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED b3d11b18-3444-4d43-b231-6a952f1c745e 61 fields · synced Jun 18, 2026