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Disposable IV Catheters

by Shandong Ande Healthcare Apparatus Co., Ltd. 12 variants

Ref ZLZ0916Model IVC02, IVC06, IVC07, IVC08, IVC09

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

CE MDR

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/MDR EUDAMED Number697044002WLZZSSTP Basic UDI-DI 16941512151037UDI-DIDate24 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number16941512151037 UDI-DI Date8 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Disposable IV Catheter
Generic Name
Peripheral intravenous cannula
Device Name
Disposable IV Catheters
Model / Reference
IVC02 EUDAMED
IVC06 EUDAMED
IVC07 EUDAMED
IVC08 EUDAMED
IVC09 EUDAMED
ZLZ0916 EUDAMED
IVC09-16 GUDID
Primary DI / UDI-DI
16941512151037
Basic UDI-DI
697044002WLZZSSTP
510(k) Number
FDA Product Code
FOZ
EMDN Code
C0101010202 Peripheral i.v. catheters, with safety systems, w/o injection valves
GMDN Term
Peripheral intravenous cannula
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5200
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
IVC02, IVC06, IVC07, IVC08, IVC09
ZLZ0916
GUDID
IVC09-16
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000011339
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shandong Ande Healthcare Apparatus Co., Ltd.

See all devices from Shandong Ande Healthcare Apparatus Co., Ltd. →

Properties

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

Other properties (18)

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