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Clever Check TD-4227 i TD-4116 Strip teste pentru masurarea nivelului de glicem…

EUDAMEDFDA 510(k)

Class IVD Annex II List B (EU MDR)

Ref TD-4302 510(k) K041107

by TaiDoc Technology Corporation

Identity

Trade Name
Clever Check TD-4227 i TD-4116 Strip teste pentru masurarea nivelului de glicemie în sânge 50 Strip teste EUDAMED
Clever Check TD-4227 i TD-4116 Strip teste pentru masurarea nivelului de glicemie în sânge 25 Strip teste EUDAMED
Device Name
Blood Glucose Test Strip EUDAMED
Model / Reference
TD-4302 EUDAMED

Identifiers

Primary DI / UDI-DI
04710469878985 EUDAMED
04710469875946 EUDAMED
Basic UDI-DI
B-04710469878985 EUDAMED
B-04710469875946 EUDAMED
EMDN Code
W0101060101 GLUCOSE TEST STRIPS EUDAMED

Classification

Device Class
Class IVD Annex II List B EUDAMED
Market of Registration
Romania EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Clever Check TD-4227 i TD-4116 Strip teste pentru masurarea nivelului de glicem… by Taidoc Technology Corporation — Class IVD Annex II List B — FDA_510K, IVDD…

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
TaiDoc Technology Corporation
EUDAMED SRN
TW-MF-000017956
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (3)

  • EUDAMED efcf4f78-cc33-4769-be88-c01cfd1d237b 85 fields · synced Jul 16, 2026
  • EUDAMED 95ae4e99-5d1b-448a-8306-6b267f19c45c 61 fields · synced May 16, 2026
  • FDA 510(k) K041107 1 fields · synced May 18, 2026