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4K UHD Foraminoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FS6342181O-4K
by Joimax GmbH
Identity
- Trade Name
- 4K UHD Foraminoscope EUDAMEDjoimax® FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- 4K UHD Foraminoscope EUDAMEDFDA UDI
- Model / Reference
- FS6342181O-4K EUDAMEDFDA UDI
- Description
- 4K UHD Foraminoscope FDA UDI
Identifiers
- Catalog Number
- FS6342181O-4K FDA UDI
- Primary DI / UDI-DI
- 04250337118480 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337118480 EUDAMED
- 510(k) Number
- K051827 FDA UDI
- FDA Product Code
- HRX FDA UDI
- EMDN Code
- Z12021199 ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Spinal endoscopic-access system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
4K UHD Foraminoscope by Joimax GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250337118480 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (2)
- EUDAMED efd7814d-ef71-45ab-9c71-3f1fc5a51c20 61 fields · synced Jul 9, 2026
- FDA UDI 53c9b956-5a03-4f3e-b8b3-9d3bd33bbf83 36 fields · synced May 30, 2026