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Oral Syringe

by Jiangsu Micsafe Medical Technology Co., Ltd 12 variants

Ref OR60CMHModel 60ml Silicone O-ring

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 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06971911290771 Basic UDI-DI 06971911290771UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971911290771 UDI-DI Date31 May 2023ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
Oral Syringe EUDAMED
micsafe GUDID
Generic Name
Blood collection tube holder/needle
Model / Reference
60ml Silicone O-ring EUDAMED
OR60CMH EUDAMED
1 GUDID
Primary DI / UDI-DI
06971911290771
Basic UDI-DI
B-06971911290771
510(k) Number
FDA Product Code
JKA
EMDN Code
A020199 Syringes, single-use - other
GMDN Term
Blood collection tube holder/needle
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
862.1675
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
60ml Silicone O-ring
OR60CMH
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