Identity
- Trade Name
- Vitalis EUDAMED
- Device Name
- Kalt-/Warm-Kompressen EUDAMED
- Model / Reference
- TS0061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050235001620 EUDAMED
- Basic UDI-DI
- 4050235PS0003BE EUDAMED
- Direct Marketing DI
- 04050235001620 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 | 4050235PS0003BE | Class I | Active |
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Manufacturer
- Manufacturer
- PS Product Services GmbH
- EUDAMED SRN
- DE-MF-000005290
Sources (1)
- EUDAMED c5493c35-164b-4b80-a0ab-a8762b5826c2 61 fields · synced Jun 18, 2026