Identity
- Trade Name
- Shears EUDAMED
- Device Name
- Procision™ Ultrasonic Surgical System EUDAMED
- Model / Reference
- P36H5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16973566721034 EUDAMED
- Basic UDI-DI
- 697356672PH01NZ EUDAMED
- Direct Marketing DI
- 16973566721034 EUDAMED
- EMDN Code
- K0202010101 ULTRASONIC OPEN SURGERY SCISSORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I 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
Shears 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 dbaa3913-8687-4bc5-a973-99fb0a0d4d9f 61 fields · synced Jun 18, 2026