Identity
- Trade Name
- Oktagon EUDAMED
- Model / Reference
- Accessories for prothetic parts EUDAMED55487 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E0HM3955487ZDRS001 EUDAMED
- Basic UDI-DI
- ++E0HM311I01AAM9 EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES 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
Oktagon by Hager & Meisinger GmbH — 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 | ++E0HM311I01AAM9 | Class I | Active |
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Manufacturer
- Manufacturer
- Hager & Meisinger GmbH
- EUDAMED SRN
- DE-MF-000004966
Sources (1)
- EUDAMED 013381aa-b879-43a0-ae38-8739072d3e01 61 fields · synced Jun 9, 2026