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
- ELEVATOR SELDIN 34S, TIN COATE EUDAMEDFDA UDI
- Model / Reference
- E34ST EUDAMEDFDA UDINordent Catalogue Hygiene Section EUDAMED
- Description
- ELEVATOR SELDIN 34S, TIN COATE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840018640108 EUDAMEDFDA UDI
- Basic UDI-DI
- 08400186010848 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
Yes
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
No
Manufacturing Date
Yes
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 | 08400186010848 | 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 ec65fcbf-e9ae-4554-ac4e-e94051ae2aee 61 fields · synced Jun 7, 2026
- FDA UDI 4e78d709-e0c9-4efc-9134-a820f9a74253 33 fields · synced May 30, 2026