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Pic CGM WEARABLE SENSOR
EUDAMEDClass IIb (EU MDR)
Ref ZKCTS01104Model CT-302Ref ZKCTS01103
Identity
- Trade Name
- Pic CGM WEARABLE SENSOR EUDAMED
- Device Name
- Sensors of Continuous Glucose Monitoring Systems EUDAMED
- Model / Reference
- CT-302 EUDAMEDZKCTS01104 EUDAMEDZKCTS01103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971141200885 EUDAMED06971141200861 EUDAMED
- Basic UDI-DI
- 697114120CT30257 EUDAMED
- EMDN Code
- Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDItaly 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
Pic CGM WEARABLE SENSOR by Zhejiang POCTech CO., Ltd. — Class IIb — 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 | 697114120CT30257 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhejiang POCTech CO., Ltd.
- EUDAMED SRN
- CN-MF-000024556
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED bb4bc463-e0d0-470d-b09c-86d7120cb520 61 fields · synced Jul 11, 2026
- EUDAMED a571c705-ad7b-4770-bbc0-a913d9c22ddb 61 fields · synced May 18, 2026