Identity
- Trade Name
- Chemolan EUDAMED
- Device Name
- Ultrasonic gel EUDAMED
- Model / Reference
- 80401 EUDAMED80415 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715478804013 EUDAMED08715478804150 EUDAMED
- Basic UDI-DI
- 8715478ULTRASONIC8B EUDAMED
- Direct Marketing DI
- 08715478804013 EUDAMED08715478804150 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
Chemolan by Chemodis — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 (2)
- EUDAMED 2b9ab0cc-c1ff-43ba-95aa-b1869f0fec0b 61 fields · synced Jul 11, 2026
- EUDAMED 92c42112-fca1-41e3-8146-2d4ac7460761 61 fields · synced May 17, 2026