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Tube products

EUDAMED

Class A (EU MDR)

Ref SC-190-B-RSModel MCT-0.6，MCT-0.6-L，T-005（MCT-150），T-005B（MCT-150），T-008，T-001，T-002，CT-1.5，CT-1.5-L，CT-1.5-B，CT-1.5-Y，CT-1.5-V，CT-1.5-P，CT-1.5-G，CT-1.5-O，CT-1.5-M，CT-2.0, etc

by Hangzhou Agen Biotechnology Co Ltd

Identity

Device Name
Tube products EUDAMED
Model / Reference
MCT-0.6，MCT-0.6-L，T-005（MCT-150），T-005B（MCT-150），T-008，T-001，T-002，CT-1.5，CT-1.5-L，CT-1.5-B，CT-1.5-Y，CT-1.5-V，CT-1.5-P，CT-1.5-G，CT-1.5-O，CT-1.5-M，CT-2.0, etc EUDAMED
SC-190-B-RS EUDAMED

Identifiers

Primary DI / UDI-DI
06979006040911 EUDAMED
Basic UDI-DI
697900604TT001HZ EUDAMED
EMDN Code
W05020199 SAMPLES TRANSPORT, CONTAINERS - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Tube products by Hangzhou Agen Biotechnology Co Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Hangzhou Agen Biotechnology Co Ltd
EUDAMED SRN
CN-MF-000049623
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 073a6815-5c0c-46ea-a18c-f0968596b4b2 61 fields · synced Jun 20, 2026