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Dilation Tube EndoLIF® Quadro M
EUDAMEDFDA UDIClass I (EU MDR)
Ref DTEQ199013
by Joimax GmbH
Identity
- Trade Name
- Dilation Tube EndoLIF® Quadro M EUDAMEDEndoLIF® FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- Dilation Tube EndoLIF® Quadro M EUDAMEDFDA UDIGuiding Tube, Rod EUDAMED
- Model / Reference
- DTEQ199013 EUDAMEDFDA UDI
- Description
- Dilation Tube EndoLIF® Quadro M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337111092 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337111092 EUDAMED42503371DILADIL9L EUDAMED
- 510(k) Number
- K151143 FDA UDI
- FDA Product Code
- MAX FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Endoscopic-access dilator, reusable 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
Dilation Tube EndoLIF® Quadro M 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-04250337111092 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337111092 | 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 21894e3c-713c-4b3d-9a49-153d153b0da3 61 fields · synced Jul 15, 2026
- EUDAMED ea4a0a78-5029-4448-b9ce-d1eab836f254 61 fields · synced May 19, 2026
- FDA UDI 99ad5933-ccf7-4295-a10b-1f1719faddb0 35 fields · synced May 30, 2026