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TESSYS® Endo-Flexprobe Handle
EUDAMEDFDA UDIClass I (EU MDR)
Ref TEFH45025
by Joimax GmbH
Identity
- Trade Name
- TESSYS® Endo-Flexprobe Handle EUDAMEDTESSYS® FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- TESSYS® Endo-Flexprobe Handle EUDAMEDFDA UDIEndo-Flexprobe EUDAMED
- Model / Reference
- TEFH45025 EUDAMEDFDA UDI
- Description
- TESSYS® Endo-Flexprobe Handle FDA UDI
Identifiers
- Catalog Number
- TEFH45025 FDA UDI
- Primary DI / UDI-DI
- 04250337101192 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337101192 EUDAMED42503371PALPENDG5 EUDAMED
- Direct Marketing DI
- 04250337101192 EUDAMED
- FDA Product Code
- GEG FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting 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® Endo-Flexprobe Handle 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-04250337101192 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337101192 | 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 5f7c2c8a-7513-4593-a951-299d2fdf7030 61 fields · synced Jul 20, 2026
- FDA UDI 8f4fe369-e625-4e2a-ba45-91083383c37d 36 fields · synced May 30, 2026
- EUDAMED fecc1225-9bd3-4e9f-babd-cd29e30ad50e 61 fields · synced Jul 20, 2026