Identity
- Device Name
- Procision™ Ultrasonic Surgical System EUDAMED
- Model / Reference
- FS82 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973566720061 EUDAMED
- Basic UDI-DI
- 697356672PH01NZ EUDAMED
- Direct Marketing DI
- 06973566720061 EUDAMED
- EMDN Code
- K020280 DEVICES FOR SURGERY WITH ULTRASONIC GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Procision™ Ultrasonic Surgical System by Shenzhen Purwell Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697356672PH01NZ | Class I | Unknown |
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Manufacturer
- Manufacturer
- Shenzhen Purwell Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012094
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED b9998721-8199-4ecf-8735-bd1a6c1da7ff 61 fields · synced Jun 18, 2026