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cCeLL - In vivo

by VPIX Medical Inc.

Ref manyModel CN100-2W2C488775, CN100-1W1C405, CN100-1W1C488, CN100-1W1C775

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

CE MDR

Valid until

7 Aug 2031

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88001124CN1007A Basic UDI-DI 08800112400161UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800112400161 UDI-DI Date11 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2026-MDR/QS-054 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    7 Aug 2026
    Expires
    7 Aug 2031

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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
cCeLL - In vivo EUDAMED
cCeLL GUDID
Generic Name
Scanning laser optical microscope
Device Name
Confocal laser endomicroscopy system
Model / Reference
CN100-2W2C488775, CN100-1W1C405, CN100-1W1C488, CN100-1W1C775, many
Primary DI / UDI-DI
08800112400161
Basic UDI-DI
88001124CN1007A
Direct Marketing DI
08800112400161
510(k) Number
FDA Product Code
GWG
EMDN Code
Z12020401 Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images
GMDN Term
Scanning laser optical microscope
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.1480
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
CN100-2W2C488775, CN100-1W1C405, CN100-1W1C488, CN100-1W1C775
many
GUDID
CN100-2W2C488775
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000039216
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from VPIX Medical, Inc.

See all devices from VPIX Medical, Inc. →

Properties

  • Sterile
  • Reusable
  • Reprocessed
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Single Use: No
  • Implantable: No
  • Contains Latex: 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No