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unidix

by Promisemed Hangzhou Meditech Co., Ltd. 16 variants

Ref HB-100, HB-065, RBC-2330H, RBC-2130H

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697122740HBX7 Basic UDI-DI Date15 Jul 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Heel Blood Lancet
Safety Blood Collection Needle;Safety Blood Collection Needle with Pre-attached Holder;Safety Winged Infusion Set
Model / Reference
HB-100, HB-065, RBC-2330H, RBC-2130H
Primary DI / UDI-DI
06978111921375, 06978111921351, 06978111920729, 06978111920705
Basic UDI-DI
697122740HBX7, 697122740RBCPE
Unit of Use DI
86978111921371, 86978111921357, 86978111920725, 86978111920701
EMDN Code
V010401, A01010501
Device Class
Class IIa
EU market of registration
Greece
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000008465
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Blood lancet, single-use

Other devices from Promisemed Hangzhou Meditech Co., Ltd.

See all devices from Promisemed Hangzhou Meditech Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No