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Zentrum BioTela

by Lianyungang baishun medical treatment articles co., ltd 3 variants

Ref BSMED02, BSMED01, 20cmx10mModel Cotton Yarn:40*40,32*32,21*21,32*21,16*16,With or without X-ray detectable thread (or tape) Mesh: 11thr,12thr,13thr,15thr,17thr,18thr,20thr,22thr,24a thr,24b thr,24c thr,21c thr,24thr,27.5thr Size: 4cm×6cm、5cm×5cm、5cm×7cm、etc, Cotton Yarn:40*40,32*32,21*21,32*21,16*16,With or without X-ray detectable thread (or tape) Mesh: 11thr,12thr,13thr,15thr,17thr,18thr,20thr,22thr,24a thr,24b thr,24c thr,21c thr,24thr,27.5thr etc

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697033651gs001S4 Basic UDI-DI Date18 Mar 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  • Withdrawn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
Gauze Swab
Gauze Roll
Medical bandage
Model / Reference
Cotton Yarn:40*40, 32*32, 21*21, 32*21, 16*16, With or without X-ray detectable thread (or tape) Mesh: 11thr, 12thr, 13thr, 15thr, 17thr, 18thr, 20thr, 22thr, 24a thr, 24b thr, 24c thr, 21c thr, 24thr, 27.5thr Size: 4cm×6cm、5cm×5cm、5cm×7cm、etc, BSMED02, 27.5thr etc, BSMED01, 20cmx10m
Primary DI / UDI-DI
06970336511836, 06970336511843, 06970336512840
Basic UDI-DI
697033651gs001S4, 697033651gr001RV, 697033651mb001QF
Direct Marketing DI
06970336511843
EMDN Code
M020199, M03030199
Device Class
Class I
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000010197
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