← Back to catalogue

VISION ESR Analyzer

EUDAMED

Class IVD General (EU MDR)

Ref V6116Model VISION-BRef V6132Model VISION-CRef V6108Model VISION-ARef V6232Model VISION Pro-C

by Shenzhen Yhlo Biotech Co., Ltd.

Identity

Trade Name
VISION ESR Analyzer EUDAMED
Device Name
VISION ESR Analyzer EUDAMED
Model / Reference
VISION-B EUDAMED
V6116 EUDAMED
VISION-C EUDAMED
V6132 EUDAMED
VISION-A EUDAMED
V6108 EUDAMED
VISION Pro-C EUDAMED
V6232 EUDAMED

Identifiers

Primary DI / UDI-DI
D-V6116U3 EUDAMED
D-V6132TZ EUDAMED
D-V6108U4 EUDAMED
D-V6232U6 EUDAMED
Basic UDI-DI
B-V6116U3 EUDAMED
B-V6132TZ EUDAMED
B-V6108U4 EUDAMED
B-V6232U6 EUDAMED
EMDN Code
W02029001 ERYTHROCYTE SEDIMENTATION RATE DEVICES EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Italy EUDAMED
Greece EUDAMED
Romania 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

Yes

EUDAMED

VISION ESR Analyzer by Shenzhen Yhlo Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shenzhen Yhlo Biotech Co., Ltd.
EUDAMED SRN
CN-MF-000001137
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (4)

  • EUDAMED 992215f0-be94-40a2-81d2-b45c0f638df5 61 fields · synced Jul 11, 2026
  • EUDAMED f4d43c78-f8c8-4e0d-9b4f-15605e97a610 61 fields · synced May 17, 2026
  • EUDAMED c6bb9b96-a482-40dd-a555-e3f9115aee3b 61 fields · synced May 17, 2026
  • EUDAMED 307fe32b-9de2-4d24-8c0e-649696c7832d 61 fields · synced May 17, 2026