TESSYS® FHD Foraminoscope (3.7 WCh), ocular
EUDAMEDFDA UDIClass IIa (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- TESSYS® FHD Foraminoscope (3.7 WCh), ocular EUDAMEDTESSYS® FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- TESSYS® FHD Foraminoscope (3.7 WCh), ocular EUDAMEDTESSYS® FHD Foraminoscope thoracic (3.1 WCh), Combo EUDAMEDTESSYS® HD Foraminoscope (3.7 mm WCh), ocular FDA UDI
- Model / Reference
- FS6342181O EUDAMEDFDA UDI
- Description
- TESSYS® HD Foraminoscope (3.7 mm WCh), ocular FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337100454 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337100454 EUDAMED42503371ENSCFORG9 EUDAMED
- Direct Marketing DI
- 04250337100454 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
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 (3.7 WCh), ocular 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-04250337100454 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337100454 | 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 a7f77d8e-a45e-4e67-8a0f-ae3accb29474 61 fields · synced Jul 20, 2026
- FDA UDI 7dd1273d-d233-4f44-88bd-7f83d70d0dd5 35 fields · synced May 27, 2026
- EUDAMED 45a254ee-7d99-4f05-906d-a96de68ac230 61 fields · synced Jul 20, 2026