Identity
- Trade Name
- FIXAtape STRETCH 5cm x 450cm blister blue EUDAMED
- Device Name
- FIXAtape STRETCH EUDAMED
- Model / Reference
- 1216 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594027318948 EUDAMED
- Basic UDI-DI
- 859402731031GY EUDAMED
- Direct Marketing DI
- 08594027318948 EUDAMED
- EMDN Code
- M030402020101 ELASTIC SUPPORT BANDAGES, COHESIVE, EXTENSIBLE IN ONE DIRECTION, HIGH EXTENSIBILITY 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
FIXAtape STRETCH 5cm x 450cm blister blue 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 | 859402731031GY | Class I | Active |
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Manufacturer
- Manufacturer
- ALFA VITA, s.r.o.
- EUDAMED SRN
- CZ-MF-000051941
Sources (1)
- EUDAMED 621a8cbd-0529-4770-b315-50f048f7ace4 61 fields · synced Aug 2, 2026