4K UHD Foraminoscope XT (3.7 WCh), ocular
EUDAMEDFDA UDIClass IIa (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- 4K UHD Foraminoscope XT (3.7 WCh), ocular EUDAMEDEndoscope FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- 4K UHD Foraminoscope XT (3.7 WCh), ocular EUDAMEDFDA UDI
- Model / Reference
- FX6342208O-4K EUDAMEDFDA UDI
- Description
- 4K UHD Foraminoscope XT (3.7 WCh), ocular FDA UDI
Identifiers
- Catalog Number
- FX6342208O-4K FDA UDI
- Primary DI / UDI-DI
- 04250337118671 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337118671 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
- Austria 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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Rigid endoscope obturator
4K UHD Foraminoscope XT (3.7 WCh), ocular by Joimax GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250337118671 | 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 efe024ae-295a-42b0-856e-fd00d37017ef 61 fields · synced Jul 18, 2026
- FDA UDI c9bcb486-b00a-42ad-867a-b289239b1ab0 37 fields · synced May 30, 2026