Identity
- Trade Name
- Vacuform 2.0 Vakuummatratze, Sigma-Lap EUDAMED
- Device Name
- Vakuummatratze EUDAMED
- Model / Reference
- 3465316 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250603600572 EUDAMED
- Basic UDI-DI
- 42506036VAKUUMKISSEN6H EUDAMED
- EMDN Code
- V80 CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMEDV080702 NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES 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
Vacuform 2.0 Vakuummatratze, Sigma-Lap by B.u.W. Schmidt 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 | 42506036VAKUUMKISSEN6H | Class I | Active |
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Manufacturer
- Manufacturer
- B.u.W. Schmidt GmbH
- EUDAMED SRN
- DE-MF-000022478
Sources (2)
- EUDAMED 3c156dc0-1966-4251-a8b3-a4cd4cd949d6 61 fields · synced Jun 19, 2026
- EUDAMED c40d2073-5f86-4136-8e42-e699cbe3825f 61 fields · synced Jun 19, 2026