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Nervnadel mit Handgriff Sortiment
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 9107.11.654SO1Model 16411
Identity
- Trade Name
- Nervnadel mit Handgriff Sortiment EUDAMEDEDENTA FDA UDI
- Generic Name
- Endodontic broach, serrated, reusable FDA UDI
- Device Name
- Endo-Instrumente EUDAMEDNerve broache with handle FDA UDI
- Model / Reference
- 16411 EUDAMED9107.11.654SO1 EUDAMEDFDA UDI
- Description
- Nerve broache with handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- E312910711654SO11 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216411DS EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
- GMDN Term
- Endodontic broach, serrated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Market of Registration
- Liechtenstein 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
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
No
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
Nervnadel mit Handgriff Sortiment by Edenta Etablissement — 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 | ++E31216411DS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (2)
- EUDAMED 4244e981-a07f-4841-b2d6-6d33bf628d16 61 fields · synced Jul 16, 2026
- FDA UDI afe94a8e-2150-4d9a-838f-7a465359c1ae 33 fields · synced May 30, 2026