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Arsci

by Arsci Biomedical Inc. 48 variants

Ref B-35FP04Model Injection Pipette, Holding Pipette, Biopsy Pipette, Denuding Pipette, Partial Zona Dissection Pipette, Assisted Hatching Pipette, Transfer Pipette

Active European Union

CE MDR

Valid until

No date given

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697519049MICROTOOLS6S Basic UDI-DI 06975190499443UDI-DIDate21 Oct 2026RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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
Microtools
Model / reference
Injection Pipette, Holding Pipette, Biopsy Pipette, Denuding Pipette, Partial Zona Dissection Pipette, Assisted Hatching Pipette, Transfer Pipette, B-35FP04
Primary DI / UDI-DI
06975190499443
Basic UDI-DI
697519049MICROTOOLS6S
EMDN code
U0802030101 Biopsy pipettes for assisted reproduction
Device class
Class IIa
EU registration type
Standard device

Manufacturer details

EUDAMED SRN
CN-MF-000041819
Authorised representative
MedPath GmbH DE-AR-000000087

Properties

  • Supplied sterile

Other properties (13)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No