Identity
- Trade Name
- Disposable Ultrasonic Shears EUDAMED
- Device Name
- Disposable Ultrasonic Shears EUDAMED
- Model / Reference
- - EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974065620678 EUDAMED
- Basic UDI-DI
- 697406562601HKAZL EUDAMED
- EMDN Code
- K0202010101 ULTRASONIC OPEN SURGERY SCISSORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Disposable Ultrasonic Shears by Surgsci Medical 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 | 697406562601HKAZL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Surgsci Medical Ltd.
- EUDAMED SRN
- CN-MF-000029791
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 575145df-19a7-4aa6-8f70-17f06e141168 61 fields · synced Jun 18, 2026