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CESSYS® Oval Working Tube w/ Handle, fenestra. 45°
EUDAMEDFDA UDIClass I (EU MDR)
Ref CWT104703 R
by Joimax GmbH
Identity
- Trade Name
- CESSYS® Oval Working Tube w/ Handle, fenestra. 45° EUDAMEDCESSYS® FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- CESSYS® Oval Working Tube w/ Handle, fenestra. 45° EUDAMEDFDA UDIWorking Tube with handle EUDAMED
- Model / Reference
- CWT104703 R EUDAMEDFDA UDI
- Description
- CESSYS® Oval Working Tube w/ Handle, fenestra. 45° FDA UDI
Identifiers
- Catalog Number
- CWT104703 R FDA UDI
- Primary DI / UDI-DI
- 04250337113935 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337113935 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® Oval Working Tube w/ Handle, fenestra. 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-04250337113935 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337113935 | 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 4b64e82a-2d5e-4db5-8043-5f4c553e2945 61 fields · synced Oct 6, 2026
- EUDAMED beb74ae2-97ac-4bc5-a7c7-463c96af8327 61 fields · synced May 18, 2026
- FDA UDI 58af6b87-9f77-475d-b1e8-015aed597ef0 36 fields · synced May 30, 2026