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Mi Long Handle Rongeur
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2598-07-690
by Tecomet, Inc
Identity
- Trade Name
- MI LONG HANDLE RONGEUR EUDAMEDTecomet FDA UDI
- Generic Name
- Spinal rongeur FDA UDI
- Device Name
- Rongeurs EUDAMEDMI LONG HANDLE RONGEUR FDA UDI
- Model / Reference
- 2598-07-690 EUDAMEDFDA UDI
- Description
- MI LONG HANDLE RONGEUR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841435119963 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841435132853U5 EUDAMED
- Direct Marketing DI
- 00841435119963 EUDAMED
- FDA Product Code
- HTX FDA UDI
- EMDN Code
- L091307 ORTHOPAEDIC SURGERY RONGEURS, REUSABLE EUDAMED
- GMDN Term
- Spinal rongeur FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium 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
Mi Long Handle Rongeur by Tecomet, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0841435132853U5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tecomet, Inc
- EUDAMED SRN
- US-MF-000027544
- Authorised Representative
- Meditec Source GmbH & Co. KG DE-AR-000009318
Sources (2)
- EUDAMED 25500607-1842-4e7c-9ad9-6192e507272d 61 fields · synced Sep 18, 2026
- FDA UDI a2cf66aa-dbb7-4cb7-ac02-4bb0e6113a43 33 fields · synced May 29, 2026