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Oral Syringe

by Jiangsu Micsafe Medical Technology Co., Ltd 12 variants

Ref OR60CSModel Opacus 60ml Rubber Piston, 60ml Rubber Piston

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

CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-26971911290973 Basic UDI-DI Date29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number26971911290973 UDI-DI Date30 Nov 2022ListedStatusListed 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Oral Syringe EUDAMED
Micsafe GUDID
Generic Name
ENFit oral/enteral syringe, single-use
Model / Reference
Opacus 60ml Rubber Piston EUDAMED
OR60CS EUDAMED
60ml Rubber Piston EUDAMED
1 GUDID
Primary DI / UDI-DI
26971911290973, 06971911290719
Basic UDI-DI
B-26971911290973, B-06971911290719
FDA Product Code
FMI, MEG, FMF
EMDN Code
A020199 Syringes, single-use - other
GMDN Term
ENFit oral/enteral syringe, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.5570, 880.5860
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Opacus 60ml Rubber Piston
OR60CS
60ml Rubber Piston
GUDID
1
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000011594
Authorised representative
Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133

Other devices from Jiangsu Micsafe Medical Technology Co., Ltd

See all devices from Jiangsu Micsafe Medical Technology Co., Ltd →

Properties

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

Other properties (14)

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