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Sinton Medical Products 100103-S

by Shenzhen Boon Medical Supply Co., Ltd.

Ref HS-DC201SModel 200 mL

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06938327909888 UDI-DI Date20 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-06938327909888 Basic UDI-DI 06938327909888UDI-DIDate26 Jun 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Sterile High-pressure Angiographic Syringes for Single-use EUDAMED
Sinton Medical Products GUDID
Generic Name
Angiography kit
Model / Ref / Catalog
200 mL, HS-DC201S, 100103-S
Description
1-200ml Syringe 1-Small Spike 1-prime tube 1-60" Coiled Tubing with Check Valve
Primary DI / UDI-DI
06938327909888
Basic UDI-DI
B-06938327909888
510(k) Number
FDA Product Code
DXT
EMDN Code
A02010401 Syringes for contrast media injector, single-use
GMDN Term
Angiography kit
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1650
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
200 mL
HS-DC201S
GUDID
100103-S
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K241109)

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Other devices from Shenzhen Boon Medical Supply Co., Ltd.

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Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No