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ACTICARE Laminated sheets 38x43 cm

by Changzhou Newrise Medical & Hygiene Products Co., Ltd

Ref AC SBOV B 1000100Model 43x38cm, 45x45cm, 50x45cm, 50x50cm, 60x50cm, 60x60cm, 75x45cm, 75x75cm, 75x90cm, 90x85cm, 90x90cm, 70x200cm, 75x140cm, 75x175cm, 75x210cm, 78x140cm, 78x175cm, 78x210cm, 80x150cm, 80x175cm, 80x210cm, 100x200cm

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697632566PROTSHTH5 Basic UDI-DI 16976325666102UDI-DIDate8 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Protective sheet
Model / Reference
43x38cm, 45x45cm, 50x45cm, 50x50cm, 60x50cm, 60x60cm, 75x45cm, 75x75cm, 75x90cm, 90x85cm, 90x90cm, 70x200cm, 75x140cm, 75x175cm, 75x210cm, 78x140cm, 78x175cm, 78x210cm, 80x150cm, 80x175cm, 80x210cm, 100x200cm, AC SBOV B 1000100
Primary DI / UDI-DI
16976325666102
Basic UDI-DI
697632566PROTSHTH5
Direct Marketing DI
16976325666102
EMDN Code
T030102 Cover sheaths, instruments and equipments
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000013196
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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