Identity
- Trade Name
- Variator-Kit EUDAMED
- Device Name
- steriles Behandlungsset, dental EUDAMED
- Model / Reference
- 005400 EUDAMED355441 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099637001210 EUDAMED
- Basic UDI-DI
- B-04099637001210 EUDAMED
- EMDN Code
- Q010508 DENTAL SURGERY INSTRUMENT KITS, SINGLE-USE 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Variator-Kit by Hager & Werken GmbH & Co. KG — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04099637001210 | Class I | Active |
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Manufacturer
- Manufacturer
- Hager & Werken GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000004938
Sources (1)
- EUDAMED 515f7c04-280a-45d5-839e-4a813f4b34aa 61 fields · synced Jun 19, 2026