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Oktagon
EUDAMEDFDA UDIClass I (EU MDR)
Ref 31167Model Accessories for prothetic parts
Identity
- Trade Name
- Oktagon EUDAMEDOKTAGON® FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- Device for prosthetic application (impression, laboratory) FDA UDI
- Model / Reference
- Accessories for prothetic parts EUDAMED31167 EUDAMEDFDA UDI
- Description
- Device for prosthetic application (impression, laboratory) FDA UDI
Identifiers
- Catalog Number
- 31167 FDA UDI
- Primary DI / UDI-DI
- E0HM311671 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E0HM311I00AAM4 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Manual non-rotary dental instrument handle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Oktagon by Hager & Meisinger GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E0HM311I00AAM4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hager & Meisinger GmbH
- EUDAMED SRN
- DE-MF-000004966
Sources (2)
- EUDAMED dc15cf89-0706-4973-af31-172670e20ad7 61 fields · synced Jun 9, 2026
- FDA UDI 4a66b8be-4d46-449f-bdfc-f004293b79df 35 fields · synced May 30, 2026