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Pregarde

by BrosMed Medical Co., Ltd 37 variants

Ref 6F045ST-C, 8F045ST-Y, 7F065ST-C, 8F065ST-C, 6F065ST-C, 6F045CO-C, 8F045MP-C, 4F065ST-C, 7F065ST-Y, 5F045RD-Y, 7F045LM-C, 8F045MP-Y, 6F045RD-C, 7F090ST-Y, 6F045LM-Y, 6F110ST-C, 7F045RD-Y, 8F090ST-C, 6F090MP-C, 7F090ST-C, 5F045CO-Y, 7F045RD-C, 5F045MP-C, 5F090MP-Y, 7F110ST-Y, 4F090ST-Y, 7F045MP-C, 7F045HS-C, 8F065ST-Y, 5F065ST-Y, 6F045RD-Y, 6F045HS-Y, 7F090MP-C, 8F090MP-Y, 8F090ST-Y, 5F045LM-C, 4F090ST-C, 6F045HS-C, 7F090MP-Y, 8F045CO-C, 5F065ST-C, 4F045ST-Y, 6F090ST-Y, 7F045MP-Y

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number695848140066MM Basic UDI-DI Date21 Oct 2025RegisteredStatusActive

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  • Withdrawn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
Pregarde Guiding Sheaths
Model / Reference
6F045ST-C, 8F045ST-Y, 7F065ST-C, 8F065ST-C, 6F065ST-C, 6F045CO-C, 8F045MP-C, 4F065ST-C, 7F065ST-Y, 5F045RD-Y, 7F045LM-C, 8F045MP-Y, 6F045RD-C, 7F090ST-Y, 6F045LM-Y, 6F110ST-C, 7F045RD-Y, 8F090ST-C, 6F090MP-C, 7F090ST-C, 5F045CO-Y, 7F045RD-C, 5F045MP-C, 5F090MP-Y, 7F110ST-Y, 4F090ST-Y, 7F045MP-C, 7F045HS-C, 8F065ST-Y, 5F065ST-Y, 6F045RD-Y, 6F045HS-Y, 7F090MP-C, 8F090MP-Y, 8F090ST-Y, 5F045LM-C, 4F090ST-C, 6F045HS-C, 7F090MP-Y, 8F045CO-C, 5F065ST-C, 4F045ST-Y, 6F090ST-Y, 7F045MP-Y
Primary DI / UDI-DI
06958481409277, 06958481409871, 06958481409437, 06958481409505, 06958481409338, 06958481409321, 06958481409482, 06958481409147, 06958481409833, 06958481409604, 06958481409413, 06958481409888, 06958481409307, 06958481409840, 06958481409710, 06958481409369, 06958481409802, 06958481409512, 06958481409352, 06958481409444, 06958481409628, 06958481409406, 06958481409192, 06958481409659, 06958481409864, 06958481409550, 06958481409390, 06958481409383, 06958481409901, 06958481409635, 06958481409703, 06958481409680, 06958481409451, 06958481409925, 06958481409918, 06958481409215, 06958481409154, 06958481409284, 06958481409857, 06958481409499, 06958481409239, 06958481409536, 06958481409741, 06958481409796
Basic UDI-DI
695848140066MM
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000007501
Authorised representative
Brosmed Medical B.V. NL-AR-000002616

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from BrosMed Medical Co., Ltd.

See all devices from BrosMed Medical 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