Identity
- Trade Name
- Fit Kofferdam Lochzange EUDAMED
- Device Name
- Kofferdam Lochzange, dental EUDAMED
- Model / Reference
- 002500 EUDAMED355321 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099637003511 EUDAMED
- Basic UDI-DI
- 409963700250045 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER 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
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
Fit Kofferdam Lochzange 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 | 409963700250045 | Class I | Active |
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Manufacturer
- Manufacturer
- Hager & Werken GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000004938
Sources (1)
- EUDAMED 96ee9dd9-140e-4fd1-8d71-fa96adcbd0d2 61 fields · synced Oct 6, 2026