Identity
- Trade Name
- Vitalis EUDAMED
- Device Name
- Neopren-Bandagen EUDAMED
- Model / Reference
- SP0142 / SP0146 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050235004102 EUDAMED
- Basic UDI-DI
- 4050235PS0005BJ EUDAMED
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Compression/pressure sock/stocking, reusable
Vitalis by PS Product Services GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Compression/pressure sock/stocking, reusable.
- PREGNANCY CORSET-M — HEGELİ ORTOPEDİK ÜRÜNLER SAN.LTD.ŞTİ · Class I
- CICATREX MASS FUSS/BEIN NAT.F. — Thuasne Deutschland GmbH · Class I
- JOBST Elvarex — Bsn-Jobst, Inc. · Class II
- Physiologix Ultimate Carpal Tunnel Brace — Fleming Medical · Class I
- Female compression pants — Eto Garments ApS · Class I
- BabyBelt — Anita Dr. Helbig GmbH · Class I
- JOBST Style — BSN MEDICAL, INC. · Class II
- Female compression bodystocking — Eto Garments ApS · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PS Product Services GmbH
- EUDAMED SRN
- DE-MF-000005290
Sources (1)
- EUDAMED 59e0cab1-dd3e-4787-b4c7-f3d54830b582 61 fields · synced Jun 19, 2026