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Vaginal/Endocervical Specimen Collection kit

EUDAMED

Class A (EU MDR)

Ref STTY03Ref STTY02Ref STTY04Ref STTY01

by Suzhou Shengtian Biotechnology Co., Ltd.

Identity

Trade Name
Vaginal/Endocervical Specimen Collection kit EUDAMED
Device Name
Vaginal/Endocervical Specimen Collection kit EUDAMED
Model / Reference
STTY03 EUDAMED
STTY02 EUDAMED
STTY04 EUDAMED
STTY01 EUDAMED

Identifiers

Primary DI / UDI-DI
06974478980574 EUDAMED
06974478980567 EUDAMED
06974478980581 EUDAMED
06974478980550 EUDAMED
Basic UDI-DI
697447898STTY03BX EUDAMED
697447898STTY02BV EUDAMED
697447898STTY04BZ EUDAMED
697447898STTY01BT EUDAMED
EMDN Code
W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
France 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

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Vaginal/Endocervical Specimen Collection kit by Suzhou Shengtian 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

EUDAMED SRN
CN-MF-000009632
Authorised Representative
Kingsmead Service B.V. NL-AR-000002066

Sources (4)

  • EUDAMED 83ffdbf8-e8bd-496f-8520-f2cc3630691d 61 fields · synced Sep 18, 2026
  • EUDAMED 11856330-89d1-4f38-808c-b39dfa6c256b 61 fields · synced May 11, 2026
  • EUDAMED 748475f1-2edf-4beb-a195-525c3de9acf8 61 fields · synced May 17, 2026
  • EUDAMED 6d229d61-cfa0-4ea4-9c98-5f8455c395e1 61 fields · synced May 17, 2026