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CESSYS® Working Tube with handle, fenestrated 45°
EUDAMEDFDA UDIClass I (EU MDR)
Ref CWT104803
by Joimax GmbH
Identity
- Trade Name
- CESSYS® Working Tube with handle, fenestrated 45° EUDAMEDCESSYS® FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- CESSYS® Working Tube with handle, fenestrated 45° EUDAMEDFDA UDIWorking Tube with handle EUDAMED
- Model / Reference
- CWT104803 EUDAMEDFDA UDI
- Description
- CESSYS® Working Tube with handle, fenestrated 45° FDA UDI
Identifiers
- Catalog Number
- CWT104803 FDA UDI
- Primary DI / UDI-DI
- 04250337108931 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337108931 EUDAMED42503371WOTULUCX3 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CESSYS® Working Tube with handle, fenestrated 45° by Joimax GmbH — Class I — 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-04250337108931 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337108931 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (3)
- EUDAMED c2e89b9c-a6df-4482-85ee-8678b033679c 61 fields · synced Jul 19, 2026
- EUDAMED a7cbaf4c-faef-4e6d-bbbe-307131459107 61 fields · synced May 18, 2026
- FDA UDI 152b33ac-8511-4d79-9a74-49213686c099 36 fields · synced May 27, 2026