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Working Tube EndoLIF® Quadro L
EUDAMEDFDA UDIClass I (EU MDR)
Ref WTEQ161513
by Joimax GmbH
Identity
- Trade Name
- Working Tube EndoLIF® Quadro L EUDAMEDEndoLIF® FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- Working Tube Chisel EUDAMEDWorking Tube EndoLIF® Quadro L EUDAMEDFDA UDI
- Model / Reference
- WTEQ161513 EUDAMEDFDA UDI
- Description
- Working Tube EndoLIF® Quadro L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337113133 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371WOTUTUBY9 EUDAMEDB-04250337113133 EUDAMED
- 510(k) Number
- K151143 FDA UDI
- FDA Product Code
- MAX FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Spinal endoscopic-access system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3080 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Working Tube EndoLIF® Quadro L 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 | 42503371WOTUTUBY9 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 42503371WOTUTUBY9 | 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 b4a1d4dd-2a72-4a3b-bb08-d7e5b081ab76 61 fields · synced Jul 9, 2026
- EUDAMED 80c59043-1b90-4123-a6b3-a011b318b214 61 fields · synced May 19, 2026
- FDA UDI fb7497fc-e8cd-4c44-9e15-5c7f2882279f 35 fields · synced May 30, 2026