Identity
- Trade Name
- Stretta Catheter Kit EUDAMEDStretta FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- Stretta Catheter EUDAMEDStretta Catheter and Accessory Kit for use only with Mederi MDRF1 Generator FDA UDI
- Model / Reference
- 8800 EUDAMEDFDA UDI175-5580 EUDAMED
- Description
- Stretta Catheter and Accessory Kit for use only with Mederi MDRF1 Generator FDA UDI
Identifiers
- Catalog Number
- 175-5580 FDA UDI
- Primary DI / UDI-DI
- 00856219002294 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00856219002294 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- G0301010101 OESOPHAGEAL BALLOON CATHETERS, LOW PRESSURE EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Stretta Catheter Kit by Respiratory Technology Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00856219002294 | 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 0d2e13af-76c8-41dc-b723-966cb445803e 61 fields · synced Jul 27, 2026
- FDA UDI b187767e-25ea-425f-b6ca-93cf9b6c4880 35 fields · synced May 30, 2026