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Haemowax

by Unisur Lifecare Private Limited India EUDAMED

Ref S 810Model S810

EMDN M040506

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2025-MDR/QS-011/A Date8 Jan 2026IssuedStatusActive expires 31 Jan 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2025-MDR/QS-011/A Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    8 Jan 2026
    Expires
    31 Jan 2030
  • 2025-MDR/TD-011/A Issued

    Technical documentation EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    8 Jan 2026
    Expires
    31 Jan 2030

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Sterile Bonewax
Model / Reference
S810, S 810
Primary DI / UDI-DI
08904300102773, 08904300103596, 08904300101561, 08904300102216, 08904300102780
Basic UDI-DI
890430012015ULSBW001XF
EMDN Code
M040506 Hemostatic waxes
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
IN-MF-000008184
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Unisur Lifecare Private Limited

See all devices from Unisur Lifecare Private Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (12)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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

Sources (5)

  • EUDAMED 2296670a-f0d1-4826-aeb0-040eb4ed292c 61 fields · synced 23 Oct 2026
  • EUDAMED 08904300103596|890430012015ULSBW001XF 61 fields · synced 23 Oct 2026
  • EUDAMED 08904300101561|890430012015ULSBW001XF 61 fields · synced 24 Oct 2026
  • EUDAMED 08904300102216|890430012015ULSBW001XF 61 fields · synced 24 Oct 2026
  • EUDAMED 08904300102780|890430012015ULSBW001XF 61 fields · synced 24 Oct 2026