Identity
- Trade Name
- FLEXASOFT® Ultraschall-Bezug unsteril EUDAMED
- Device Name
- Ultraschall Bezug unsteril EUDAMED
- Model / Reference
- 31812U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251806203102 EUDAMED
- Basic UDI-DI
- 42518062008LC EUDAMED
- EMDN Code
- T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT 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
FLEXASOFT® Ultraschall-Bezug unsteril by Udo Heisig GmbH The Disposables Company — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: FLEXASOFT® Ultraschall-Bezug für Gel (31011) REF 31011 110 x 450/50 mm
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 | 42518062008LC | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Udo Heisig GmbH The Disposables Company
- EUDAMED SRN
- DE-MF-000009334
Sources (1)
- EUDAMED e685ff70-6bde-4e80-bcbf-7f1c70bfee37 61 fields · synced Jun 18, 2026