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LinX
EUDAMEDClass IIb (EU MDR)
Ref 1034-FMTL-083Model GX-01S；GX-02SRef 1034-FMTL-058Ref 1034-FMTL-072Ref 1034-FMTL-042Ref 1034-FMTL-086Ref 1034-FMTL-020
Identity
- Trade Name
- LinX EUDAMED
- Device Name
- Continuous Glucose Monitoring System Sensor EUDAMED
- Model / Reference
- GX-01S；GX-02S EUDAMED1034-FMTL-083 EUDAMED1034-FMTL-058 EUDAMED1034-FMTL-072 EUDAMED1034-FMTL-042 EUDAMED1034-FMTL-086 EUDAMED1034-FMTL-020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958590310273 EUDAMED06958590309550 EUDAMED06958590309758 EUDAMED06958590309093 EUDAMED06958590331032 EUDAMED06958590307495 EUDAMED
- Basic UDI-DI
- 69585903Z1204011502GXSDM EUDAMED
- Direct Marketing DI
- 06958590310273 EUDAMED06958590309550 EUDAMED06958590309758 EUDAMED06958590309093 EUDAMED06958590331032 EUDAMED06958590307495 EUDAMED
- EMDN Code
- Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Estonia EUDAMEDItaly EUDAMEDHungary EUDAMEDTürkiye 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
LinX by Microtech Medical (hangzhou) 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 | 69585903Z1204011502GXSDM | Class IIb | Active |
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Manufacturer
- Manufacturer
- MicroTech Medical (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001157
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (6)
- EUDAMED e2a04f1a-4bfe-421c-9032-0726139ec338 61 fields · synced Jul 31, 2026
- EUDAMED 12db6c4b-2278-495d-999b-ae4322818911 61 fields · synced May 17, 2026
- EUDAMED 924db9e8-7106-426e-af58-3f5d5c80f5c7 61 fields · synced May 18, 2026
- EUDAMED 4cdb3758-3184-4c5a-ad21-d439b4d38bf0 61 fields · synced May 19, 2026
- EUDAMED 0ba8690c-0564-404f-b0b8-5780b72aeb3a 61 fields · synced Jul 10, 2026
- EUDAMED 7755e95a-413a-48fb-ad9a-2659174fb467 61 fields · synced Jul 18, 2026