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Working Tube Shaft, Standard Lip, iLESSYS DELTA
EUDAMEDFDA UDIClass I (EU MDR)
Ref WTS901300.3
by Joimax GmbH
Identity
- Trade Name
- Working Tube Shaft, Standard Lip, iLESSYS DELTA EUDAMEDiLESSYS® FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Working Tube Shaft EUDAMEDWorking Tube Shaft, Standard Lip, iLESSYS DELTA EUDAMEDFDA UDI
- Model / Reference
- WTS901300.3 EUDAMEDFDA UDI
- Description
- Working Tube Shaft, Standard Lip, iLESSYS DELTA FDA UDI
Identifiers
- Catalog Number
- WTS901300.3 FDA UDI
- Primary DI / UDI-DI
- 04250337110415 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371WOTUSCSXG EUDAMEDB-04250337110415 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
Working Tube Shaft, Standard Lip, iLESSYS DELTA by Joimax GmbH — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 42503371WOTUSCSXG | Class I | Active |
| EUDAMED | European Union | CE/MDR | 42503371WOTUSCSXG | 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 62654976-a8f2-4619-8514-89f5ff8e6622 61 fields · synced Jul 25, 2026
- EUDAMED 8dc1fd1d-a4d7-43dc-8cfe-c09f99e37f4b 61 fields · synced May 19, 2026
- FDA UDI e13d9a8e-b4c1-46b1-8879-4072fbc11ef6 36 fields · synced May 30, 2026