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TESSYS® Guiding Tube, conical, yellow
EUDAMEDFDA UDIClass I (EU MDR)
Ref GTC194353
by Joimax GmbH
Identity
- Trade Name
- TESSYS® Guiding Tube, conical, yellow EUDAMEDTESSYS® FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- TESSYS® Guiding Tube, conical, yellow EUDAMEDFDA UDIGuiding Tube, Rod EUDAMED
- Model / Reference
- GTC194353 EUDAMEDFDA UDI
- Description
- TESSYS® Guiding Tube, conical, yellow FDA UDI
Identifiers
- Catalog Number
- GTC194353 FDA UDI
- Primary DI / UDI-DI
- 04250337102984 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337102984 EUDAMED42503371DILADIL9L EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Endoscopic-access dilator, 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
TESSYS® Guiding Tube, conical, yellow 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-04250337102984 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337102984 | 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 3ce53fa2-5007-4d7f-a322-db3d0a891084 61 fields · synced Sep 18, 2026
- EUDAMED 64b4a2ea-86ce-4804-bf02-46168dd806b4 61 fields · synced May 19, 2026
- FDA UDI 318bdce5-02fd-4ea2-a66e-77fc7159457b 36 fields · synced May 30, 2026