Identity
- Trade Name
- Miratray OK S2 12er EUDAMED
- Device Name
- Abformlöffel, einmalige Anwendung EUDAMED
- Model / Reference
- 000200 EUDAMED101171 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099637002866 EUDAMED
- Basic UDI-DI
- 409963700020038 EUDAMED
- Unit of Use DI
- 04099637002859 EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, 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
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
Category: Dental impression tray, single-use
Miratray OK S2 12er by Hager & Werken GmbH & Co. KG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 409963700020038 | Class I | Active |
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Manufacturer
- Manufacturer
- Hager & Werken GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000004938
Sources (1)
- EUDAMED 4980af69-7158-41fc-a29c-a5ae25425cd9 61 fields · synced Jul 9, 2026