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FLEXASOFT® Ultraschall-Bezug für Gel
EUDAMEDClass I (EU MDR)
Ref 31013Ref 31905Ref 31100Ref 31912Ref 31803Ref 31825Ref 31808Ref 31011Ref 31812
Identity
- Trade Name
- FLEXASOFT® Ultraschall-Bezug für Gel EUDAMEDFLEXASOFT® Ultraschall-Bezug EUDAMEDFLEXASOFT® Ultraschall-Bezug fur Gel EUDAMED
- Device Name
- Ultraschall Bezug EUDAMED
- Model / Reference
- 31013 EUDAMED31905 EUDAMED31100 EUDAMED31912 EUDAMED31803 EUDAMED31825 EUDAMED31808 EUDAMED31011 EUDAMED31812 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251806203294 EUDAMED04251806200569 EUDAMED04251806203218 EUDAMED04251806200606 EUDAMED04251806200439 EUDAMED04251806200521 EUDAMED04251806200477 EUDAMED04251806200293 EUDAMED04251806200507 EUDAMED
- Basic UDI-DI
- 42518062001KW EUDAMED
- EMDN Code
- T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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 für Gel 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 | 42518062001KW | Class I | Active |
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Manufacturer
- Manufacturer
- Udo Heisig GmbH The Disposables Company
- EUDAMED SRN
- DE-MF-000009334
Sources (9)
- EUDAMED d307d5b7-9d4d-485e-aacb-ae021f9d81fe 61 fields · synced Oct 6, 2026
- EUDAMED 438414bf-56e6-47b8-a987-eeea451ef943 61 fields · synced May 17, 2026
- EUDAMED 486d1cd0-9822-4dc1-ab58-b9c29ad1e5c9 61 fields · synced May 18, 2026
- EUDAMED 784f5fe4-252a-4c52-8aaf-bb1841bb3206 61 fields · synced May 18, 2026
- EUDAMED f9bbc97d-2955-46ca-83f4-027713e2a3ed 61 fields · synced May 18, 2026
- EUDAMED 1fff1a6e-e861-4701-a55a-f0d60986baf9 61 fields · synced May 18, 2026
- EUDAMED 400f800b-cff0-4bd2-aba9-ec422af3c892 61 fields · synced May 18, 2026
- EUDAMED f328ca09-2cac-4cef-8081-6cd8aae95060 61 fields · synced May 19, 2026
- EUDAMED 5f67ebf7-7d99-4849-b7e1-218fff087485 61 fields · synced May 19, 2026