MDRF1 Generator
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- MDRF1 Generator EUDAMEDMederi MDRF1 Generator FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- MDRF1 Generator EUDAMEDMederi MDRF1 Generator Monopolar generator to be used only with Secca and Stretta catheters FDA UDI
- Model / Reference
- MDRF1 Generator 177-5150 EUDAMEDMederi Radiofrequency Generator EUDAMEDMDRF1 FDA UDI
- Description
- Mederi MDRF1 Generator Monopolar generator to be used only with Secca and Stretta catheters FDA UDI
Identifiers
- Catalog Number
- 177-5150 FDA UDI
- Primary DI / UDI-DI
- 00856219002102 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00856219002102 EUDAMED
- 510(k) Number
- K103017 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Electrosurgical system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Electrical-only medical device connection cable, reusable
MDRF1 Generator by Respiratory Technology Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00856219002102 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Respiratory Technology Corporation
- EUDAMED SRN
- US-MF-000009086
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 81b9bdfa-61a7-4e65-95ba-0840ae5dbdd5 61 fields · synced Jul 22, 2026
- FDA UDI 2c323aa8-de28-4457-8ccc-51141d72be4e 36 fields · synced May 30, 2026