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Disposable Electrosurgical Pencil
EUDAMEDClass IIb (EU MDR)
Ref P16NModel HEP16Ref HEP4Ref HEP12Ref P4NRef HEP10Ref P10NRef P8NModel HEP8Ref HEP7
Identity
- Trade Name
- Disposable electrosurgical pencil EUDAMED
- Device Name
- Disposable Electrosurgical Pencil EUDAMED
- Model / Reference
- HEP16 EUDAMEDP16N EUDAMEDHEP4 EUDAMEDHEP12 EUDAMEDP4N EUDAMEDHEP10 EUDAMEDP10N EUDAMEDHEP8 EUDAMEDP8N EUDAMEDHEP7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944375394149 EUDAMED06944375391506 EUDAMED06944375391544 EUDAMED06944375394088 EUDAMED06944375391568 EUDAMED06944375391537 EUDAMED06944375394118 EUDAMED06944375394101 EUDAMED06944375391513 EUDAMED
- Basic UDI-DI
- B-06944375394149 EUDAMEDB-06944375391506 EUDAMEDB-06944375391544 EUDAMEDB-06944375394088 EUDAMEDB-06944375391568 EUDAMEDB-06944375391537 EUDAMEDB-06944375394118 EUDAMEDB-06944375394101 EUDAMEDB-06944375391513 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDCzechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Disposable Electrosurgical Pencil by Zhejiang Haisheng Medical Device Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06944375394149 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhejiang Haisheng Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000026345
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (9)
- EUDAMED ed5e7ebd-4c5c-46a8-a86b-80bdd09748dd 61 fields · synced Aug 3, 2026
- EUDAMED 41abf01a-0f5b-4c53-992c-17ba55e04c81 61 fields · synced May 17, 2026
- EUDAMED 7fdaeff9-b1bc-4010-93e8-00bc0bebf945 61 fields · synced May 17, 2026
- EUDAMED dc728b88-4b46-4283-9e2a-6603fd6b53b4 61 fields · synced May 18, 2026
- EUDAMED 542364fc-17fb-4ceb-9ca8-bd78f1cc99c3 61 fields · synced May 18, 2026
- EUDAMED e935acf1-8ea8-4c1c-bf96-871ffda1a8b3 61 fields · synced May 18, 2026
- EUDAMED 6dc9e367-d03d-49a3-9dd8-f2a81fd026cd 61 fields · synced May 18, 2026
- EUDAMED 8d0ae526-d135-4404-93a2-911afe14934a 61 fields · synced May 18, 2026
- EUDAMED 237ef422-000a-4fc2-a321-b67a19a4339c 61 fields · synced May 18, 2026