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Suction Safe™ Swivel Y

by Nextphase Medical Devices LLC 2 variants

Ref A1003Model A1002 Each

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 linked in EUDAMED

A group certificate may exist

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
European UnionCE/MDR EUDAMED Number0859758005SSSHB Basic UDI-DI 00859758005023UDI-DIDate5 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00859758005023 UDI-DI Date20 Feb 2025ListedStatusListed GUDID: in commercial distribution

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

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  • Withdrawn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
Sontek Medical
Generic Name
Anaesthesia breathing circuit, single-use
Device Name
Suction Safe™ Swivel Y
Model / Reference
A1002 Each EUDAMED
A1003 EUDAMED
A1003 Each GUDID
Primary DI / UDI-DI
00859758005023
Basic UDI-DI
0859758005SSSHB
FDA Product Code
BZA
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Anaesthesia breathing circuit, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5810
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
A1002 Each
A1003
GUDID
A1003 Each
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000047498
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Device sterilization/disinfection container, reusable

Other devices from Nextphase Medical Devices LLC

See all devices from Nextphase Medical Devices LLC →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No