Skip to content

Nephrostomy Balloon Dilator with Amplatz Sheath & Inflation device

by Blue Neem Medical Devices Private Limited

Ref BNB000505502

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8905080BPDGH Basic UDI-DI 08905080010616UDI-DIDate21 Apr 2026RegisteredStatusActive

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  • Withdrawn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
Percutaneous Dilators
Model / Reference
BNB000505502
Primary DI / UDI-DI
08905080010616
Basic UDI-DI
8905080BPDGH
EMDN Code
U03010199 Percutaneous nephrostomy, sequential dilators - other
Device Class
Class IIa
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
IN-MF-000021793
Authorised representative
Arazy Group (Ireland) Ltd. IE-AR-000000093

Other devices from Blue Neem Medical Devices Private Limited

See all devices from Blue Neem Medical Devices Private Limited →

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