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Emergency trauma Cold compress bandage

by Sinopharm Health Biotechnology (Mount Huangshan) Co. Ltd EUDAMED

Active European Union

Ref XZBD-05Model XZBD-01 10*10cm，XZBD-02 20*10cm，XZBD-03 30*10cm，XZBD-04 35*10cm，XZBD-05 40*10cm，XZBD-06 45*10cm，XZBD-07 50*10cm，XZBD-08 55*10cm，XZBD-09 60*10cm

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6971562101ETCCB7P Basic UDI-DIDate16 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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

Device Name
Emergency trauma Cold compress bandage
Model / Reference
XZBD-01 10*10cm，XZBD-02 20*10cm，XZBD-03 30*10cm，XZBD-04 35*10cm，XZBD-05 40*10cm，XZBD-06 45*10cm，XZBD-07 50*10cm，XZBD-08 55*10cm，XZBD-09 60*10cm, XZBD-05
Primary DI / UDI-DI
06971562102195
Basic UDI-DI
6971562101ETCCB7P
EMDN Code
M0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.)
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000055858
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

Other properties (13)

  • Sterile: No
  • 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