TESSYS® FHD Foraminoscope (4.7 WCh), combo
EUDAMEDFDA UDIClass IIa (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- TESSYS® FHD Foraminoscope (4.7 WCh), combo EUDAMEDTESSYS® FHD Foraminoscope (4.7 WCh), combo EUDAMEDTESSYS® FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- TESSYS® FHD Foraminoscope (4.7 WCh), combo EUDAMEDTESSYS® FHD Foraminoscope thoracic (3.1 WCh), Combo EUDAMEDTESSYS® FHD Foraminoscope (4.7 WCh), combo FDA UDI
- Model / Reference
- FS7347171C EUDAMEDFDA UDI
- Description
- TESSYS® FHD Foraminoscope (4.7 WCh), combo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337110583 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337110583 EUDAMED42503371ENSCFORG9 EUDAMED
- Direct Marketing DI
- 04250337110583 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 EUDAMEDGermany 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
No
Category: Rigid endoscope obturator
TESSYS® FHD Foraminoscope (4.7 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
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337110583 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337110583 | 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 46052686-bec4-4980-926c-9344491f3938 61 fields · synced Jun 19, 2026
- FDA UDI 0f3cb14f-0539-445d-84ba-65ba9baf4dd5 35 fields · synced May 30, 2026
- EUDAMED 8c1ef3f9-613f-487f-becf-5fb9628acae7 61 fields · synced Jun 19, 2026