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Puyuan

by Guangzhou Fuzelong Hygiene Material Co., Lt 30 variants

Ref SP-7000, GE-431203R, 302-204, GE-1304, GE-1204AR, SD-5007, 302-203, SD-8003, 201-2301(with Ties),Type II, SP-5003, GE-411104R, SH-1001, 201-2301(with Ties),Type IIR, 201-1301 (with Ear loops) ,Type II, SP-3001, SD-4000, SP-1100, SD-1100，Laparotomy Drape, SD-5006, GE-1205TR, SD-1407, GE-1204T, SD-7000, SD-6003, GE-411202, GE-1204, SD-2105, GE-1204R, SP-8100Model Standard performance；High 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 Number69218257SSK5R Basic UDI-DI Date11 Feb 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Sterile Surgical Packs
Sterile Surgical Gowns
Sterile Surgical Drapes
Surgical Masks
Sterile Medical Hoods
Model / Reference
SP-7000, Standard performance；High performance, GE-431203R, 302-204, GE-1304, GE-1204AR, SD-5007, 302-203, SD-8003, 201-2301(with Ties), Type II, SP-5003, GE-411104R, SH-1001, Type IIR, 201-1301 (with Ear loops), SP-3001, SD-4000, SP-1100, SD-1100，Laparotomy Drape, SD-5006, GE-1205TR, SD-1407, GE-1204T, SD-7000, SD-6003, GE-411202, GE-1204, SD-2105, GE-1204R, SP-8100
Primary DI / UDI-DI
06921825700927, 06921825703454, 06921825701122, 06921825703423, 06921825703393, 06921825701221, 06921825701054, 06921825701276, 06921825701405, 06921825700958, 06921825701115, 06921825703508, 06921825701078, 06921825701085, 06921825701436, 06921825701412, 06921825701337, 06921825700989, 06921825701214, 06921825701030, 06921825701160, 06921825701245, 06921825703447, 06921825701290, 06921825703485, 06921825701269, 06921825701252, 06921825701061, 06921825703461, 06921825703478, 06921825701184, 06921825703522, 06921825703515, 06921825700903, 06921825701092, 06921825701016, 06921825701153
Basic UDI-DI
69218257SSK5R, 69218257SSG5H, 69218257SSD5B, 69218257SFM4N, 69218257SCEP
EMDN Code
T0299, T020402, T020401, T020199, T020699, T030501
Device Class
Class I
EU market of registration
Germany
France

Manufacturer details

EUDAMED SRN
CN-MF-000023141
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Guangzhou Fuzelong Hygiene Material Co., Lt

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Properties

  • Sterile
  • Contains Latex NoEUDAMEDYesEUDAMED
  • Reprocessed NoEUDAMEDYesEUDAMED

Other properties (10)

  • Implantable: No
  • Reusable: 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