Identity
- Trade Name
- Vitalis EUDAMED
- Device Name
- Neopren-Bandagen EUDAMED
- Model / Reference
- SP0116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050235001125 EUDAMED
- Basic UDI-DI
- 4050235PS0005BJ EUDAMED
- Direct Marketing DI
- 04050235001125 EUDAMED
- EMDN Code
- M0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Vitalis by PS Product Services GmbH — 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 | 4050235PS0005BJ | Class I | Active |
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Manufacturer
- Manufacturer
- PS Product Services GmbH
- EUDAMED SRN
- DE-MF-000005290
Sources (1)
- EUDAMED 708e0f4c-6544-41a8-8ce8-991f1243a378 61 fields · synced Jun 18, 2026