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TESSYS® Guiding Rod, conical, red
EUDAMEDFDA UDIClass I (EU MDR)
Ref GRC222050
by Joimax GmbH
Identity
- Trade Name
- TESSYS® Guiding Rod, conical, red EUDAMEDTESSYS® FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- Guiding Tube, Rod EUDAMEDTESSYS® Guiding Rod, conical, red EUDAMEDFDA UDI
- Model / Reference
- GRC222050 EUDAMEDFDA UDI
- Description
- TESSYS® Guiding Rod, conical, red FDA UDI
Identifiers
- Catalog Number
- GRC222050 FDA UDI
- Primary DI / UDI-DI
- 04250337100553 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371DILADIL9L EUDAMEDB-04250337100553 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 Rod, conical, red 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 | 42503371DILADIL9L | Class I | Active |
| EUDAMED | European Union | CE/MDR | 42503371DILADIL9L | 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 c348419f-d251-4818-a189-e80fae2e4136 61 fields · synced Jun 18, 2026
- EUDAMED a0dc63d3-863c-499f-b994-5fdfddda05ad 61 fields · synced May 19, 2026
- FDA UDI 59a83f9f-d2e3-4351-9e95-a64aea52f3b7 36 fields · synced May 30, 2026