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Thermoplastic Radiotherapy Immobilization Mask

by Xinxiang City Rongjun Medical Apparatus Co, Ltd.

Ref Type A U-shaped Mask: 2562652.4 (Porosity: 22%)Model 1.Type A U-shaped Mask: 2562652.4 (Porosity: 22%, 36%) 2.Type B Extended Mask: 2563152.4 (Porosity: 22%, 36%) 3.Sliding Track Mask: 2562652.4 (Porosity: 22%, 36%) Buckle , 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 Number697394987TRIM2V Basic UDI-DI 06973949871502UDI-DIDate23 Jul 2026RegisteredStatusActive

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  • Withdrawn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
Thermoplastic Radiotherapy Immobilization Mask
Model / Reference
1.Type A U-shaped Mask: 2562652.4 (Porosity: 22%, 36%) 2.Type B Extended Mask: 2563152.4 (Porosity: 22%, 36%) 3.Sliding Track Mask: 2562652.4 (Porosity: 22%, 36%) Buckle, etc., Type A U-shaped Mask: 2562652.4 (Porosity: 22%)
Primary DI / UDI-DI
06973949871502
Basic UDI-DI
697394987TRIM2V
EMDN Code
Z12011285 Patient positioning instruments - consumables
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000057262
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xinxiang City Rongjun Medical Apparatus Co.ltd

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