Identity
- Trade Name
- HYDRAGEL APPLICATORS 18 (10) EUDAMED
- Device Name
- HYDRAGEL APPLICATORS 18 (10) EUDAMED
- Model / Reference
- 4198 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03607360041987 EUDAMED
- Basic UDI-DI
- 3607364198BUEN EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Hydragel Applicators 18 (10) by Sebia — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 3607364198BUEN | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- sebia
- EUDAMED SRN
- FR-MF-000003520
Sources (1)
- EUDAMED 55a1b29b-43c0-48bb-92d2-b463847f858f 61 fields · synced Jul 9, 2026