Identity
- Trade Name
- Renew XR Handpiece, 42cm EUDAMEDReNew FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- ReNew Handpieces EUDAMEDReNew XR Handpiece, 42cm FDA UDI
- Model / Reference
- 3942 EUDAMEDFDA UDI
- Description
- ReNew XR Handpiece, 42cm FDA UDI
Identifiers
- Catalog Number
- 3942 FDA UDI
- Primary DI / UDI-DI
- 00811099013778 EUDAMEDFDA UDI
- Basic UDI-DI
- 081109901DOC003S9 EUDAMED
- Direct Marketing DI
- 00811099013778 EUDAMED
- 510(k) Number
- K201884 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L1203 LAPAROSCOPIC AND THORACOSCOPIC SURGERY MANIPULATORS, REUSABLE EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Renew XR Handpiece, 42cm by Microline Surgical, Inc. — Class IIa — 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 | 081109901DOC003S9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Microline Surgical, Inc.
- EUDAMED SRN
- US-MF-000009811
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 60a8e4c5-f37d-44c5-b549-019c7bd0c9e5 61 fields · synced May 31, 2026
- FDA UDI d94efd02-1e8d-4b8b-8989-96cd986c275c 35 fields · synced May 30, 2026