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Blood Sampler

by Edan Instruments, Inc. 9 variants

Ref isafeC-100BN

Blood Sampler (isafeC-100BN) is a Class A device made by Edan Instruments, Inc., registered in EUDAMED on 9 Apr 2026 (Basic UDI-DI 69444138isafeCsCD), active as of 23 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69444138isafeCsCD Basic UDI-DI Date9 Apr 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / reference
isafeC-100BN
Primary DI / UDI-DI
06944413826083, 06944413834774
Basic UDI-DI
69444138isafeCsCD
EMDN code
W0501010203 Blood collection, capillary tubes
Device class
Class A
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009957
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under BLOOD COLLECTION, CAPILLARY TUBES.

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties

  • Contains animal tissues or cells
  • Professional testing
Other properties (11, all answered No)