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Varios CR-1

by Nakanishi Inc.

Ref Z221080Model MDA0000140

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 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
European UnionCE/MDR EUDAMED Number456022498000014072 Basic UDI-DI 04589551386741UDI-DIDate11 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04589551386741 UDI-DI Date21 Jan 2026ListedStatusListed 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 24 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  • Withdrawn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
Varios
Generic Name
Instrument tray, reusable
Model / Reference
MDA0000140 EUDAMED
Z221080 EUDAMED
CR-1 GUDID
Primary DI / UDI-DI
04589551386741
Basic UDI-DI
456022498000014072
Direct Marketing DI
04589551387144
510(k) Number
FDA Product Code
ELC
EMDN Code
S0199 Devices for sterilisation and packaging (excluding cat. d - z) - other
GMDN Term
Instrument tray, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.4850
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MDA0000140
Z221080
GUDID
CR-1
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K113530)

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Other devices from Nakanishi Inc.

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No