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DiaExpert

EUDAMED

Class IIb (EU MDR)

Ref C046001Model GX-01F, GX-02FRef RC2111Ref C046000

by MicroTech Medical (Hangzhou) Co., Ltd.

Identity

Trade Name
DiaExpert EUDAMED
Device Name
Continuous Glucose Monitoring System sensor EUDAMED
Continuous Glucose Monitoring App EUDAMED
Model / Reference
GX-01F, GX-02F EUDAMED
C046001 EUDAMED
RC2111 EUDAMED
C046000 EUDAMED

Identifiers

Primary DI / UDI-DI
06958590309697 EUDAMED
06958590309840 EUDAMED
06958590309628 EUDAMED
Basic UDI-DI
69585903Z120401GXE4Y EUDAMED
69585903Z120401GXEIOSSK EUDAMED
Direct Marketing DI
06958590309840 EUDAMED
EMDN Code
Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Z1204011599 BLOOD SUGAR MONITORING SYSTEMS - OTHER EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMEDEUDAMED

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

DiaExpert 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

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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 (3)

  • EUDAMED df7a6f34-8af4-42f2-9163-399ae92e4588 61 fields · synced Jul 31, 2026
  • EUDAMED 2a1eb1e9-57ed-4659-a657-3f559919f5bf 61 fields · synced May 18, 2026
  • EUDAMED ad676e96-d5d7-4377-abee-25a28538891b 61 fields · synced May 18, 2026