Oktagon® 95268
by Hager & Meisinger Gesellschaft mit beschränkter Haftung EUDAMEDGUDID
Active
Ref 95268Model Surgical hand-held instruments
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number++E0HM209I04ACPY | Date24 Aug 2026 | StatusActive |
| United States | GUDID listing GUDID | NumberE0HM952681 | Date15 Sep 2021 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- Trade Name
- Oktagon EUDAMEDOktagon® GUDID
- Generic Name
- Manual non-rotary dental instrument handle
- Model / Ref / Catalog
- 95268, Surgical hand-held instruments
- Primary DI / UDI-DI
- E0HM952681
- Basic UDI-DI
- ++E0HM209I04ACPY
- FDA Product Code
- GFF
- EMDN Code
- Q0199 Odontology devices - other
- GMDN Term
- Manual non-rotary dental instrument handle
- Device Class
- Class I
- Regulation Number
- 878.4820
- Market of Registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
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Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No