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ActivSight Laparoscope - 10.0 mm 0 Degree

by Activ Surgical, Inc.

Ref AS-LAP100Model ActivSight Laparoscopes

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850016403SCOPESW5 Basic UDI-DI 00850016403261UDI-DIDate22 Aug 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number00850016403261 UDI-DI Date26 May 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 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  • Withdrawn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
ActivSight Laparoscope - 10.0 mm 0 Degree EUDAMED
ActivSight Laparoscope 10mm 0 Degree NIR GUDID
Generic Name
Rigid video laparoscope
Model / Reference
ActivSight Laparoscopes, AS-LAP100
Primary DI / UDI-DI
00850016403261
Basic UDI-DI
0850016403SCOPESW5
Direct Marketing DI
00850016403261
510(k) Number
FDA Product Code
GCJ
EMDN Code
Z12029009 Laparoscopes
GMDN Term
Rigid video laparoscope
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000019220
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Activ Surgical, Inc.

See all devices from Activ Surgical, Inc. →

Properties

  • Reusable
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • 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