Identity
- Trade Name
- Newclip Instruments FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Instrumentation class IIa with measuring function EUDAMED
- Model / Reference
- KIT-SC2.6F EUDAMEDFDA UDI
Identifiers
- Catalog Number
- KIT-SC2.6F FDA UDI
- Primary DI / UDI-DI
- 03700569633882 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700569600669E EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
Yes
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: General internal orthopaedic fixation system implantation kit
Newclip Instruments by Newclip Technics — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Newclip Technics
Sources (2)
- FDA UDI 6cde3c9a-f921-47ac-9275-df66278ac34f 33 fields · synced Jul 14, 2026
- EUDAMED cc11642f-b3f2-420a-817c-0a389faa7524 61 fields · synced Jul 14, 2026