Identity
- Trade Name
- Disposable Ultrasonic Scalpel EUDAMED
- Device Name
- Disposable Ultrasonic Scalpel EUDAMED
- Model / Reference
- MP1500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070992590 EUDAMED
- Basic UDI-DI
- 697507099DUS00ND EUDAMED
- Direct Marketing DI
- 06975070992590 EUDAMED
- EMDN Code
- Z12010801 ULTRASONIC SCALPEL EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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 Scalpel by Shenzhen Edge Medical 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 | 697507099DUS00ND | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Edge Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000039045
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 10ed4556-c54c-428a-80d4-4653ec6c4447 61 fields · synced Jun 18, 2026