Thyroid Stimulating Hormone Chemiluminescence Immunoassay Kit

EUDAMED

Class IVD General (EU MDR)

Ref 100tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kitRef 50tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kit

by Nanjing RealMind Biotech Co., Ltd.

Identity

Device Name: Thyroid Stimulating Hormone Chemiluminescence Immunoassay Kit EUDAMED
Model / Reference: Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit EUDAMED
100tests/kit EUDAMED
Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kit EUDAMED
50tests/kit EUDAMED

Identifiers

Primary DI / UDI-DI: 06972719604227 EUDAMED
06972719604234 EUDAMED
Basic UDI-DI: B-06972719604227 EUDAMED
B-06972719604234 EUDAMED
EMDN Code: W01020410 THYROID STIMULATING HORMONE EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Hungary EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Thyroid Stimulating Hormone Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-06972719604227	Class IVD General	Active

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Manufacturer

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
EUDAMED SRN: CN-MF-000024838
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (2)

EUDAMED 263a084e-4f4f-4939-bcca-6705364f02ef 61 fields · synced Oct 6, 2026
EUDAMED 756fa923-7fa7-45e3-8450-d89160d98290 61 fields · synced May 19, 2026