Identity
- Trade Name
- Quines Medigel EUDAMED
- Device Name
- Ultrasonic gel EUDAMED
- Model / Reference
- 80441 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715478804419 EUDAMED
- Basic UDI-DI
- 8715478ULTRASONIC8B EUDAMED
- Direct Marketing DI
- 08715478804419 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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: Device sterilization/disinfection container, reusable
Quines Medigel by Chemodis — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Device sterilization/disinfection container, reusable.
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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 | 8715478ULTRASONIC8B | Class I | Active |
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Manufacturer
- Manufacturer
- Chemodis
- EUDAMED SRN
- NL-MF-000023248
Sources (1)
- EUDAMED 45bb1940-35c4-446f-aa0a-c322a47a3383 61 fields · synced Jul 14, 2026