Identity
- Device Name
- Inksafe Tattoo Barrier Film EUDAMED
- Model / Reference
- JF0800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5060924460000129Y4Z EUDAMED
- Basic UDI-DI
- B-5060924460000129Y4Z EUDAMED
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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: Scar-management dressing, reusable
Inksafe Tattoo Barrier Film by JFA Medical Ltd. — 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-5060924460000129Y4Z | 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 4cfbe0ea-9f28-45f4-9297-ad044792a6da 61 fields · synced Jun 18, 2026