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Sterile Single-Use Electrosurgical Pencil
EUDAMEDClass IIb (EU MDR)
Ref FF100Ref FD100HRef FD100L
Identity
- Trade Name
- Sterile Single-Use Electrosurgical Pencil EUDAMED
- Device Name
- Sterile Single-Use Electrosurgical Pencil EUDAMED
- Model / Reference
- FF100 EUDAMEDFD100H EUDAMEDFD100L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972111600032 EUDAMED06972111600025 EUDAMED06972111600001 EUDAMED
- Basic UDI-DI
- 6972111609A8 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMEDCzechia 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
Sterile Single-Use Electrosurgical Pencil by MSB Medical (Wuhan) Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6972111609A8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- MSB Medical (Wuhan) Co., Ltd.
- EUDAMED SRN
- CN-MF-000026108
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED edc414d1-592f-4800-9249-2355647cd645 61 fields · synced Jul 22, 2026
- EUDAMED e19ab95b-579c-4fc6-b78e-a360c2778cdd 61 fields · synced May 17, 2026
- EUDAMED 710758d7-0376-48e9-9621-7cca85038427 61 fields · synced May 19, 2026