Identity
- Trade Name
- FLEXASOFT® Ultraschall-Bezug für Gel EUDAMED
- Device Name
- Ultraschall Bezug EUDAMED
- Model / Reference
- 31016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251806203249 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
Category: Vascular booties
FLEXASOFT® Ultraschall-Bezug für Gel by Udo Heisig GmbH The Disposables Company — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 42518062001KW | Class I | Active |
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Manufacturer
- Manufacturer
- Udo Heisig GmbH The Disposables Company
- EUDAMED SRN
- DE-MF-000009334
Sources (1)
- EUDAMED 78373ced-228e-490c-89c5-6ff919c27e17 61 fields · synced Jun 19, 2026