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Disposable Vinyl Examination Gloves, Powder Free, S

by Shandong Blue Sail Innovation Co., Ltd

Ref Vinyl EM seriesModel EM 0101

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06973022280153 UDI-DI Date25 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697302228EM01002471765L Basic UDI-DI 06973022280153UDI-DIDate9 Feb 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Disposable Vinyl Examination Gloves, Powder Free, S EUDAMED
Blue Sail GUDID
Generic Name
Vinyl examination/treatment glove, non-powdered
Model / Reference
EM 0101 EUDAMED
Vinyl EM series EUDAMED
Vinyl Medical series GUDID
Primary DI / UDI-DI
06973022280153
Basic UDI-DI
697302228EM01002471765L
Direct Marketing DI
06973022280153
FDA Product Code
LYZ
EMDN Code
T01020201 Vinyl examination / treatment gloves
GMDN Term
Vinyl examination/treatment glove, non-powdered
Device Class
Class I
Regulation Number
880.6250
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
EM 0101
Vinyl EM series
GUDID
Vinyl Medical series
Contains LatexEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
CN-MF-000001291
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shandong Blue Sail Innovation Co., Ltd.

See all devices from Shandong Blue Sail Innovation Co., Ltd. →

Properties

  • Single Use
  • Contains Latex NoEUDAMEDYesGUDID
  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Implantable: No
  • Reusable: 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No