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TESSYS® FHD Foraminoscope (3.7 WCh), combo
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FS6342181CRef EKS244041CU
by Joimax GmbH
Identity
- Trade Name
- TESSYS® FHD Foraminoscope (3.7 WCh), combo EUDAMEDEndo-Kerrison-Shaft, 40° EUDAMEDTESSYS® FDA UDIEndo-Kerrison FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDIFlexible endoscopic biopsy forceps, reusable FDA UDI
- Device Name
- TESSYS® FHD Foraminoscope (3.7 WCh), combo EUDAMEDEndo-Kerrison Shaft EUDAMEDTESSYS® FHD Foraminoscope thoracic (3.1 WCh), Combo EUDAMEDTESSYS® HD Foraminoscope (3.7 mm WCh), combo FDA UDIEndo-Kerrison-Shaft, 40° FDA UDI
- Model / Reference
- FS6342181C EUDAMEDFDA UDIEKS244041CU EUDAMEDFDA UDI
- Description
- TESSYS® HD Foraminoscope (3.7 mm WCh), combo FDA UDIEndo-Kerrison-Shaft, 40° FDA UDI
Identifiers
- Catalog Number
- EKS244041CU FDA UDI
- Primary DI / UDI-DI
- 04250337114666 EUDAMEDFDA UDI04250337100447 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337114666 EUDAMED42503371PUNCHENDWR EUDAMED42503371ENSCFORG9 EUDAMED
- Direct Marketing DI
- 04250337114666 EUDAMED04250337100447 EUDAMED
- 510(k) Number
- K051827 FDA UDI
- FDA Product Code
- HRX FDA UDILRY FDA UDI
- EMDN Code
- Z12021199 ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER EUDAMEDL1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Spinal endoscopic-access system FDA UDIFlexible endoscopic biopsy forceps, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 888.1100 FDA UDI878.4800 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
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 UDIFDA UDI
Lot / Batch Number
No
FDA UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid endoscope obturator
TESSYS® FHD Foraminoscope (3.7 WCh), combo by Joimax GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-04250337114666 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337114666 | 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 (5)
- EUDAMED f2810230-75c2-4e28-9937-af9e5b883d53 61 fields · synced Jul 26, 2026
- FDA UDI 39fa4a19-7e3b-4e35-8fff-37a6b9c1ba08 35 fields · synced May 30, 2026
- FDA UDI b2df4b11-633e-4632-bbcd-7baf677b44bb 36 fields · synced May 30, 2026
- EUDAMED 7fdb82d6-5ad3-456e-81c5-10496846948c 61 fields · synced Jul 9, 2026
- EUDAMED 7d785602-1285-4f99-9037-b2effedc4fc5 61 fields · synced Jul 26, 2026