Nordent Manufacturing, Inc.
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Nordent Manufacturing, Inc. EUDAMEDNORDENT MANUFACTURING INC FDA UDI
- Generic Name
- Bone lever/elevator, reusable FDA UDI
- Device Name
- Luxation Blade, SE, 5 mm, Curved, Titanium Nitride Coated EUDAMEDLUXATING ELEVATOR, 5MM CURVED, FDA UDI
- Model / Reference
- ELX5CT EUDAMEDFDA UDINordent Surgical Catalogue EUDAMED
- Description
- LUXATING ELEVATOR, 5MM CURVED, FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840018640498 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840018640498SR EUDAMED
- FDA Product Code
- EMJ FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Bone lever/elevator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
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
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Surgical retraction system, reusable
Nordent Manufacturing, Inc. by Nordent Manufacturing Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0840018640498SR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nordent Manufacturing Inc.
- EUDAMED SRN
- US-MF-000048439
- Authorised Representative
- Ukens Dental DE-AR-000022084
Sources (2)
- EUDAMED 96d309d0-002b-464c-9db5-e021103611f0 61 fields · synced May 31, 2026
- FDA UDI bb2a07fd-4884-49c0-9b0c-5b02c220f2f5 33 fields · synced May 29, 2026