Identity
- Device Name
- Spot-Check Monitor EUDAMED
- Model / Reference
- PC-102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941900606487 EUDAMED
- Basic UDI-DI
- 69419006PC102017T EUDAMED
- Direct Marketing DI
- 06941900606487 EUDAMED
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spot-Check Monitor by Shenzhen Creative Industry Co., Ltd. — Class IIa — 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 | 69419006PC102017T | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Creative Industry Co., Ltd.
- EUDAMED SRN
- CN-MF-000009430
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED eb68b31b-b590-4c61-9ada-9c426ecab31f 61 fields · synced Jul 28, 2026