Skip to content

wellgrow

by Shenzhen Wellgrow Biotech Co., Ltd. China EUDAMED

Ref 304701E,304702E,304704E,304705E EMDN W0103080199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-001092 Basic UDI-DIDate7 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
CD61 Apc
Model / Reference
304701E, 304702E, 304704E, 304705E
Primary DI / UDI-DI
D-001092
Basic UDI-DI
B-001092
EMDN Code
W0103080199 Monoclonal antibodies for cell surface antigens - other
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000022880
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Wellgrow Biotech Co., Ltd.

See all devices from Shenzhen Wellgrow Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 915cc6aa-93fb-4528-b100-b05b5e3cfa36 61 fields · synced 22 Oct 2026