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Promisemed

by Promisemed Hangzhou Meditech Co., Ltd.

Ref HB-065, BL-30G, ALS-01, BL-28G, HB-150, BL-32G, SL-28-18T510(k) K210946

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210946↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697122740HBX7 Basic UDI-DI Date15 Jul 2022RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK210946 Date12 Aug 2021ClearedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
Heel Blood Lancet
Blood Lancets
Alcohol Swabs
Safety Blood Lancets
Model / Reference
HB-065, BL-30G, ALS-01, BL-28G, HB-150, BL-32G, SL-28-18T
Primary DI / UDI-DI
06971227400437, 06971227405760, 06978111925045, 06978111922471, 06971227400574, 06971227401625, 06971227400567, 06971227400468, 06971227400581, 06971227408839, 06975965295065, 06975965293177, 06978111929432
Basic UDI-DI
697122740HBX7, 697122740BLX9, 697122740ALSNP, 697122740SLYU
Unit of Use DI
86971227400433, 86971227405766, 86978111925041, 86978111922477, 86971227400570, 86971227401621, 86971227400563, 86971227400464, 86971227400587, 86971227408835, 86975965295061, 86975965293173, 86978111929438
510(k) Number
FDA Product Code
KNW
EMDN Code
V010401, V010402, M0202030102
Device Class
Class IIa EUDAMED
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 876.1075
EU market of registration
Finland
Germany
Austria
Greece
Sweden
France
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
Class I
510(k)
Class II

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