Identity
- Trade Name
- Fit-Kofferdam-Latex EUDAMED
- Device Name
- Kofferdam, dental EUDAMED
- Model / Reference
- 002600 EUDAMED355335 EUDAMED355336 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099637003597 EUDAMED04099637003610 EUDAMED
- Basic UDI-DI
- 40996370026004A EUDAMED
- Unit of Use DI
- 04099637003603 EUDAMED
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Fit-Kofferdam-Latex by Hager & Werken GmbH & Co. KG — 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 | 40996370026004A | Class I | Active |
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Manufacturer
- Manufacturer
- Hager & Werken GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000004938
Sources (2)
- EUDAMED fbfb7cd0-2385-47ce-b2dc-2cd70aa40aca 61 fields · synced Oct 6, 2026
- EUDAMED 30e2e808-9453-471b-933a-cdc6b2f2c21e 61 fields · synced May 19, 2026