Identity
- Trade Name
- FIXAplast TAPE 2.5CM X5M EUDAMED
- Device Name
- FIXAplast TAPE EUDAMED
- Model / Reference
- 1043 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594027312533 EUDAMED
- Basic UDI-DI
- 859402731007H3 EUDAMED
- Direct Marketing DI
- 08594027312533 EUDAMED
- EMDN Code
- M050101 PLASTERS ON SPOOLS (ROLLS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
FIXAplast TAPE 2.5CM X5M by ALFA VITA, s.r.o. — 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 | 859402731007H3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ALFA VITA, s.r.o.
- EUDAMED SRN
- CZ-MF-000051941
Sources (1)
- EUDAMED af9c4d44-0a59-4f68-b136-9ed35947f969 61 fields · synced Oct 6, 2026