Identity
- Device Name
- Electro Surgery Bipolar Forceps EUDAMED
- Model / Reference
- 301-5-20020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973770672286 EUDAMED
- Basic UDI-DI
- 697377067301NH EUDAMED
- EMDN Code
- Z12010985 ELECTROSURGERY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Electro Surgery Bipolar Forceps by Comepa medical device Co., Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, single-use.
- ARIS COBLATION Turbinate Reduction Wand — Smith & Nephew, Inc. · Class II
- AESCULAP — AESCULAP, INC. · Class II
- BE-ST Bipolar Forceps Straight — LACEY MANUFACTURING COMPANY LLC · Class II
- Coblation — Smith & Nephew, Inc. · Class II
- Valleylab — Covidien LP · Class II
- Burs — JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- PLASMASORD — Gyrus Acmi, Inc. · Class II
- CoolSeal™ Trinity — Justright Surgical · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697377067301NH | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Comepa medical device Co., Ltd
- EUDAMED SRN
- CN-MF-000025234
- Authorised Representative
- COMEPA INDUSTRIES FR-AR-000007911
Sources (1)
- EUDAMED 3fdde241-f08f-44c8-86e4-452c3c62c74d 61 fields · synced Aug 1, 2026