Identity
- Trade Name
- Foot switch EUDAMED
- Device Name
- Procision™ Ultrasonic Surgical System EUDAMED
- Model / Reference
- MKF-21S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973566720085 EUDAMED
- Basic UDI-DI
- 697356672PH01NZ EUDAMED
- Direct Marketing DI
- 06973566720085 EUDAMED
- EMDN Code
- K020280 DEVICES FOR SURGERY WITH ULTRASONIC GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Foot switch 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 41a188ab-17fb-420b-b0cb-55cc61a0ba07 61 fields · synced Jun 18, 2026