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CESSYS® Dorsal Working Tube with Handle, Short Lip
EUDAMEDFDA UDIClass I (EU MDR)
Ref WTS68758500
by Joimax GmbH
Identity
- Trade Name
- CESSYS® Dorsal Working Tube with Handle, Short Lip EUDAMEDCESSYS® FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- CESSYS® Dorsal Working Tube with Handle, Short Lip EUDAMEDFDA UDIWorking Tube Chisel EUDAMED
- Model / Reference
- WTS68758500 EUDAMEDFDA UDI
- Description
- CESSYS® Dorsal Working Tube with Handle, Short Lip FDA UDI
Identifiers
- Catalog Number
- WTS68758500 FDA UDI
- Primary DI / UDI-DI
- 04250337116851 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337116851 EUDAMED42503371WOTUTUBY9 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® Dorsal Working Tube with Handle, Short Lip 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-04250337116851 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337116851 | 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 3f9d2399-61b0-4e03-b3f3-84f65232afc2 61 fields · synced Jul 16, 2026
- EUDAMED e457ea20-b06a-449c-8d61-2b49f361ea94 61 fields · synced May 17, 2026
- FDA UDI 508022ac-4ecc-4a5b-a53a-f5034948ab58 36 fields · synced May 30, 2026