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Sensors of Continuous Glucose Monitoring Systems
EUDAMEDClass IIb (EU MDR)
Ref ZKCTS01101Model CT-302Ref ZKCTS01201Model CT-312
Identity
- Device Name
- Sensors of Continuous Glucose Monitoring Systems EUDAMED
- Model / Reference
- CT-302 EUDAMEDZKCTS01101 EUDAMEDCT-312 EUDAMEDZKCTS01201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971141200564 EUDAMED06971141200588 EUDAMED
- Basic UDI-DI
- 697114120CT30257 EUDAMED697114120CT3125A EUDAMED
- EMDN Code
- Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Sensors of Continuous Glucose Monitoring Systems 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 4e2ec5c2-295f-450a-a164-7ccd7d622ee3 61 fields · synced Oct 6, 2026
- EUDAMED 9f9f7f6c-468f-4781-9830-1e85128965ed 61 fields · synced May 18, 2026