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Axiom
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref OPFBR16Model Drill with Altis treat. - Service set
by anthogyr
Identity
- Trade Name
- Axiom EUDAMEDAXIOM® FDA UDI
- Generic Name
- Screw extractor, single-use FDA UDI
- Device Name
- 1.6MM RE-WORKING DRILL STOP FDA UDI
- Model / Reference
- Drill with Altis treat. - Service set EUDAMEDOPFBR16 EUDAMEDFDA UDI
- Description
- 1.6MM RE-WORKING DRILL STOP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663394164788 EUDAMEDFDA UDI
- Basic UDI-DI
- 36633940046R2 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Screw extractor, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Axiom by anthogyr — Class IIa — 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 | 36633940046R2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- anthogyr
- EUDAMED SRN
- FR-MF-000000602
Sources (2)
- EUDAMED 0c72097b-9aa7-48a8-9a19-f25fb0540f85 61 fields · synced May 30, 2026
- FDA UDI ecaa07df-cae2-4773-86bc-a189605261b7 33 fields · synced May 30, 2026