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Sterile Surgical gown

by Allmed Medical Products Co., Ltd 9 variants

Ref AMSY0006, 0650XL, AMSY0002, 0650M, AMSY0003, AMSY0007, 1998.04, 1996.01, 0651L, 1998.03, 0651S, 1998.02, AMSY0001, 0651XL, AMSY0008, 1996.02, AMSY0004, 0650S, 0651M, 0650XXXL, AMSY0005, 1998.05, 1998.06, 0650XXLModel reinforced style-normal performance, standard style-normal performance

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 linked in EUDAMED

A group certificate may exist

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 Number69415580surgicalgownsPNN Basic UDI-DI Date15 Aug 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Securetex
Device Name
Sterile Surgical gown
Model / Reference
reinforced style-normal performance, AMSY0006, standard style-normal performance, 0650XL, AMSY0002, 0650M, AMSY0003, AMSY0007, 1998.04, 1996.01, 0651L, 1998.03, 0651S, 1998.02, AMSY0001, 0651XL, AMSY0008, 1996.02, AMSY0004, 0650S, 0651M, 0650XXXL, AMSY0005, 1998.05, 1998.06, 0650XXL
Primary DI / UDI-DI
46941558074643, 46941558067089, 46941558074605, 06941558067074, 06941558074614, 06941558074577, 06941558082633, 06941558082565, 46941558074520, 06941558067050, 06941558082619, 46941558067119, 06941558082596, 06941558074515, 46941558067133, 46941558074599, 06941558074584, 46941558074575, 46941558082570, 46941558067072, 06941558074621, 46941558074568, 46941558074629, 06941558067067, 06941558074560, 06941558067128, 46941558074667, 06941558067104, 46941558074551, 46941558082594, 46941558067058, 46941558082600, 46941558082617, 46941558074537, 46941558067126, 06941558067081, 06941558074522, 46941558074612, 46941558067065, 46941558082624, 06941558074591, 06941558067111, 06941558074607, 46941558082563, 06941558067135, 06941558067098, 46941558067102, 06941558074539
Basic UDI-DI
69415580surgicalgownsPNN, 69415580surgicalgownS79
EMDN Code
T020402, T020401
Device Class
Class I
EU market of registration
Portugal
Italy
Germany
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000007970
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Allmed Medical Products Co., Ltd

See all devices from Allmed Medical Products Co., Ltd →

Properties

  • Sterile

Other properties (12)

  • 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