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Spinal Endoscope, OD: 5.3mm, WC: 2.8mm, Length: 181mm, 30°
EUDAMEDClass IIa (EU MDR)
Ref 10-2016
Identity
- Device Name
- Spinal Endoscope, OD: 5.3mm, WC: 2.8mm, Length: 181mm, 30° EUDAMED
- Model / Reference
- 10-2016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810026181948 EUDAMED
- Basic UDI-DI
- 008100261810-2016FP EUDAMED
- Direct Marketing DI
- 00810026181948 EUDAMED
- EMDN Code
- Z12020903 SPINOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Spinal Endoscope, OD: 5.3mm, WC: 2.8mm, Length: 181mm, 30° by Soniquence, LLC — Class IIa — 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 | 008100261810-2016FP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Soniquence, LLC
- EUDAMED SRN
- US-MF-000029810
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 5f4c0d8f-55e8-4d44-91b4-012ab6e5c4d0 61 fields · synced Jul 10, 2026