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FLEXASOFT® Ultraschall-Bezug unsteril
EUDAMEDClass I (EU MDR)
Ref 31808URef 31825URef 31805URef 31803U
Identity
- Trade Name
- FLEXASOFT® Ultraschall-Bezug unsteril EUDAMED
- Device Name
- Ultraschall Bezug unsteril EUDAMED
- Model / Reference
- 31808U EUDAMED31825U EUDAMED31805U EUDAMED31803U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251806203096 EUDAMED04251806203119 EUDAMED04251806203089 EUDAMED04251806203072 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
Category: Vascular booties
FLEXASOFT® Ultraschall-Bezug unsteril by Udo Heisig GmbH The Disposables Company — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Vascular booties.
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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 |
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Manufacturer
- Manufacturer
- Udo Heisig GmbH The Disposables Company
- EUDAMED SRN
- DE-MF-000009334
Sources (4)
- EUDAMED 6bb6cfdf-bebb-48ad-a2aa-19927d6c74dc 61 fields · synced Aug 3, 2026
- EUDAMED f8b0c164-b7bc-4426-bd3d-367a7b97e8c1 61 fields · synced May 17, 2026
- EUDAMED a564c143-14f0-4acd-92f6-dfb6248640fc 61 fields · synced May 17, 2026
- EUDAMED 544ea3d2-5fe9-4478-a914-a1ef7345b1b0 61 fields · synced May 18, 2026