← Back to catalogue
Working Tube with Handle, double Lip
EUDAMEDFDA UDIClass I (EU MDR)
Ref WTS127505
by Joimax GmbH
Identity
- Trade Name
- Working Tube with Handle, double Lip EUDAMEDWorking sleeve FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Working Tube with Handle, double Lip EUDAMEDFDA UDIWorking Tube Chisel EUDAMED
- Model / Reference
- WTS127505 EUDAMEDFDA UDI
- Description
- Working Tube with Handle, double Lip FDA UDI
Identifiers
- Catalog Number
- WTS127505 FDA UDI
- Primary DI / UDI-DI
- 04250337110330 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337110330 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
Working Tube with Handle, double 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-04250337110330 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337110330 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (3)
- EUDAMED e30b12c4-7281-409d-b702-b1cf4ec44054 61 fields · synced Jun 18, 2026
- EUDAMED c864bcbc-8608-4388-a91b-438a809cc610 61 fields · synced May 19, 2026
- FDA UDI 880d9812-2edc-40a6-87d9-a11177dbe5d8 36 fields · synced May 25, 2026