Identity
- Trade Name
- Renew XR Handpiece 25cm EUDAMEDReNew FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- ReNew Handpieces EUDAMEDReNew XR Handpiece, 25cm FDA UDI
- Model / Reference
- 3943 EUDAMEDFDA UDI
- Description
- ReNew XR Handpiece, 25cm FDA UDI
Identifiers
- Catalog Number
- 3943 FDA UDI
- Primary DI / UDI-DI
- 00811099013785 EUDAMEDFDA UDI
- Basic UDI-DI
- 081109901DOC003S9 EUDAMED
- Direct Marketing DI
- 00811099013785 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical instrument handle, non-torque-limiting
Renew XR Handpiece 25cm by Microline Surgical, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 5edeb74b-66f3-4c0c-b02b-313508f534e4 61 fields · synced Jul 11, 2026
- FDA UDI 0596bfab-5252-41ee-8f17-9a9998e76d7d 35 fields · synced May 29, 2026