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Probe cover kit

by Exact Medical Manufacturing, Inc EUDAMED

Active European Union

Ref P6449, P6418, 1303116, E6341, V2000, E6445, E6329G, E6331, P6413, P6450, E6415, E6428, 1303565, 1304816, E6332G, E6439N, 1304833, E6349G, E6413, E6432N, E6345, E6442, E6448N, E6302N, E6360, P6339G, E6431, E6343, E6347N, E6452, E6328G, E6322N, E6427, E6441, 1302112, E6412, E6359, E6410, P6336G, E6402, P6435A, E6418, E6333, E6407, E6336G, E6440, E6447N, E6417N, 1304631, 63053-01, AM7001

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697542419SP05NS Basic UDI-DIDate25 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Trade Name
Probe cover kit
Probe Cover
Device Name
Microscope Drape
C-Arm kit
Model / Reference
P6449, P6418, 1303116, E6341, V2000, E6445, E6329G, E6331, P6413, P6450, E6415, E6428, 1303565, 1304816, E6332G, E6439N, 1304833, E6349G, E6413, E6432N, E6345, E6442, E6448N, E6302N, E6360, P6339G, E6431, E6343, E6347N, E6452, E6328G, E6322N, E6427, E6441, 1302112, E6412, E6359, E6410, P6336G, E6402, P6435A, E6418, E6333, E6407, E6336G, E6440, E6447N, E6417N, 1304631, 63053-01, AM7001
Primary DI / UDI-DI
06975424190573, 06975424190610, 06975085709657, 06975424191044, 06975085709596, 06975424190757, 06975424191129, 06975424191105, 06975424190627, 06975424190566, 06975424190900, 06975424190863, 06975085709671, 06975085709770, 06975424191099, 06975085707622, 06975085709787, 06975424190993, 06975424190917, 06975085708414, 06975424191013, 06975424190771, 06975085708803, 06975424193246, 06975424191150, 06975424190658, 06975424190849, 06975424191037, 06975085708483, 06975424190689, 06975424191136, 06975085707561, 06975424190870, 06975424190788, 06975085709640, 06975424190924, 06975424191143, 06975424190931, 06975424190665, 06975424190962, 06975424190580, 06975424190887, 06975424191082, 06975424190948, 06975424191075, 06975424190795, 06975085708797, 06975085709060, 06975085709695
Basic UDI-DI
697542419SP05NS, 697508570EC07JD, 697508570EC03J5, 697542419SP01NJ
EMDN Code
T0202, T030102, T030199
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000001406
Authorised representative
Exact Medical Manufacturing B.V. NL-AR-000000452

Other devices from Exact Medical Manufacturing, Inc

See all devices from Exact Medical Manufacturing, Inc →

Properties

  • Sterile YesEUDAMEDNoEUDAMED

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