← Back to catalogue
Extremities Stabilizer Kit, Flex Coils
EUDAMEDClass I (EU MDR)
Ref NC074004Model Flex Coil Accessories
by NeoCoil, LLC
Identity
- Trade Name
- Extremities Stabilizer Kit, Flex Coils EUDAMED
- Device Name
- Flex Coil Accessories EUDAMED
- Model / Reference
- Flex Coil Accessories EUDAMEDNC074004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850028932131 EUDAMED
- Basic UDI-DI
- 0850028932357L EUDAMED
- EMDN Code
- Z1105018099 MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Extremities Stabilizer Kit, Flex Coils by Neocoil, Llc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850028932357L | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NeoCoil, LLC
- EUDAMED SRN
- US-MF-000027128
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED a12e8c00-74f1-43e8-b3f3-0dea8b56bfdc 61 fields · synced Jul 25, 2026