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Sterile Disposable Plasma Surgical Electrodes
EUDAMEDClass IIb (EU MDR)
Ref F11104015Model A0101, A0201, A0301, B0111, B0211, B0311, B0121, C0101
Identity
- Device Name
- Sterile Disposable Plasma Surgical Electrodes EUDAMED
- Model / Reference
- A0101, A0201, A0301, B0111, B0211, B0311, B0121, C0101 EUDAMEDF11104015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972210545791 EUDAMED
- Basic UDI-DI
- 697221054CE1400000173 EUDAMED
- EMDN Code
- K02030101 RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Portugal 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 Disposable Plasma Surgical Electrodes by Star Sports Medicine 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 | 697221054CE1400000173 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Star Sports Medicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000027866
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED dd5317ff-5127-4cb1-8a9f-45adeda6a477 61 fields · synced Oct 6, 2026