Identity
- Device Name
- Ultrasonic surgical system generator EUDAMED
- Model / Reference
- SG100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939282409451 EUDAMED
- Basic UDI-DI
- 69392824USSG1000G3 EUDAMED
- Direct Marketing DI
- 06939282409451 EUDAMED
- EMDN Code
- Z12010801 ULTRASONIC SCALPEL EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
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
Ultrasonic surgical system generator by B.j.zh.f.panther Medical Equipment 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 | 69392824USSG1000G3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- B.J.ZH.F.Panther Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000018084
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED b4ad4082-5017-4fb0-9e3a-9f4372f9314b 61 fields · synced Jul 28, 2026