Identity
- Trade Name
- PreGel EUDAMED
- Device Name
- VDF EUDAMED
- Model / Reference
- VDF EUDAMEDJ91A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060722251673 EUDAMED
- Basic UDI-DI
- 506072225AAA0014JT EUDAMED
- EMDN Code
- D0899 DETERGENTS FOR MEDICAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMEDBelgium 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
PreGel by Amity Limited — 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 | 506072225AAA0014JT | Class I | Active |
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Manufacturer
- Manufacturer
- Amity Limited
- EUDAMED SRN
- GB-MF-000023321
- Authorised Representative
- Amity Healthcare EU Ltd. IE-AR-000011613
Sources (2)
- EUDAMED 710f18c0-6f25-43fd-bf6b-80d18e21b526 61 fields · synced Jul 21, 2026
- EUDAMED 928d1709-8468-4b0b-80bb-3989c9afeb24 61 fields · synced Jul 21, 2026