Open-surgery electrosurgical handpieces / electrodes
by Zhejiang Medstar Technology Co., Ltd. EUDAMED
Active
Ref PS07-K70, PB01-KGYHL, PB01-KGYH, EKS01-152E, EKS01-63GY, PB01-KSL, EKM01-63GYE, PE02-10FR, EKS01-50, EKS01-70E, PN03-052, P-H1, PR02-053, PE01-10FR, EKM01-63, PB01-KSH, EKM01-70GYE, P-F1, PN03-083, PS07-K2XGY, EKS01-50GY, PF02-081, EKS01-165, EKS01-70, PR03-052, PS07-K70GY, PN02-081, EKW01-100SE, PR02-081, EKM01-63GY, PE02-12FR, PR03-083, EKW01-100GYE, PR03-081, PN02-050, PR02-082, PF02-080, PN02-080, P-F2, EKW01-100, PR03-080, EKM01-70E, PE02-8FR, PR03-082, ESE-CN3, PB01-KH, PN02-051, PR03-051, EKW01-152S, PR02-083, PB01-NModel PS
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697215505PS001DX | Date23 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Open-surgery electrosurgical handpieces / electrodes
- Model / Reference
- PS, PS07-K70, PB01-KGYHL, PB01-KGYH, EKS01-152E, EKS01-63GY, PB01-KSL, EKM01-63GYE, PE02-10FR, EKS01-50, EKS01-70E, PN03-052, P-H1, PR02-053, PE01-10FR, EKM01-63, PB01-KSH, EKM01-70GYE, P-F1, PN03-083, PS07-K2XGY, EKS01-50GY, PF02-081, EKS01-165, EKS01-70, PR03-052, PS07-K70GY, PN02-081, EKW01-100SE, PR02-081, EKM01-63GY, PE02-12FR, PR03-083, EKW01-100GYE, PR03-081, PN02-050, PR02-082, PF02-080, PN02-080, P-F2, EKW01-100, PR03-080, EKM01-70E, PE02-8FR, PR03-082, ESE-CN3, PB01-KH, PN02-051, PR03-051, EKW01-152S, PR02-083, PB01-N
- Primary DI / UDI-DI
- 06972155050008, 06972155051784, 06972155051722, 06972155052699, 06972155052477, 06972155051876, 06972155052972, 06972155052293, 06972155052354, 06972155052538, 06972155050732, 06972155051517, 06972155051005, 06972155052200, 06972155052910, 06972155051845, 06972155053092, 06972155050398, 06972155050886, 06972155050091, 06972155052392, 06972155051487, 06972155052750, 06972155052514, 06972155051210, 06972155050039, 06972155050589, 06972155053252, 06972155051067, 06972155052958, 06972155052323, 06972155051364, 06972155053214, 06972155051302, 06972155050435, 06972155051098, 06972155051456, 06972155050558, 06972155050411, 06972155053153, 06972155051272, 06972155053054, 06972155052262, 06972155051333, 06972155050312, 06972155051609, 06972155050466, 06972155051180, 06972155053351, 06972155051128, 06972155051937
- Basic UDI-DI
- 697215505PS001DX
- Direct Marketing DI
- 069721550500080697215505178406972155051722069721550526990697215505247706972155051876069721550529720697215505229306972155052354069721550525380697215505073206972155051517069721550510050697215505220006972155052910069721550518450697215505309206972155050398069721550508860697215505009106972155052392069721550514870697215505275006972155052514069721550512100697215505003906972155050589069721550532520697215505106706972155052958069721550523230697215505136406972155053214069721550513020697215505043506972155051098069721550514560697215505055806972155050411069721550531530697215505127206972155053054069721550522620697215505133306972155050312069721550516090697215505046606972155051180069721550533510697215505112806972155051937
- EMDN Code
- K0201010201, K0201010302
- Device Class
- Class IIb
- Market of Registration
- DenmarkFrance
Manufacturer details
- EUDAMED SRN
- CN-MF-000028154
- Authorised representative
- Obelis s.a. BE-AR-000000106
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Properties
Other properties (12)
- Implantable: No
- Reusable: No
- 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