Pch-36
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. United States EUDAMED
Ref PCH-36Model FC-14
EMDN K0202010201,K0202010202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69449040AB051100035Y | Date9 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- FC-14, PCH-36
- Primary DI / UDI-DI
- 06903053078382
- Basic UDI-DI
- 69449040AB051100035Y
- EMDN Code
- K0202010201,K0202010202
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 3ecc6bf4-f029-4fdc-9fef-19b963854aec