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TESSYS® FHD Foraminoscope XT, (3.7 WCh), combo
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FX6342208C
by Joimax GmbH
Identity
- Trade Name
- TESSYS® FHD Foraminoscope XT, (3.7 WCh), combo EUDAMEDTESSYS® FHD Foraminoscope XT, (3.7 WCh), combo EUDAMEDTESSYS® FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- TESSYS® FHD Foraminoscope XT, (3.7 WCh), combo EUDAMEDTESSYS® FHD Foraminoscope thoracic (3.1 WCh), Combo EUDAMEDTESSYS® HD Foraminoscope XT, (3.7 mm WCh), combo FDA UDI
- Model / Reference
- FX6342208C EUDAMEDFDA UDI
- Description
- TESSYS® HD Foraminoscope XT, (3.7 mm WCh), combo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337100485 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337100485 EUDAMED42503371ENSCFORG9 EUDAMED
- Direct Marketing DI
- 04250337100485 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
- Netherlands EUDAMEDGermany 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
EUDAMEDEUDAMED
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
TESSYS® FHD Foraminoscope XT, (3.7 WCh), combo by Joimax GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337100485 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337100485 | 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 (3)
- EUDAMED 7d186542-729b-4ab7-88f7-d904d401f99c 61 fields · synced Jul 30, 2026
- FDA UDI 6e891b90-e8fe-4532-aa74-bdf112058a73 35 fields · synced May 30, 2026
- EUDAMED e7ec135d-af93-43c7-8e48-1c94cfbff8ca 61 fields · synced Jul 30, 2026