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envision Transducer Cover H2O-008, H2O-008-5

by Civco Medical Instruments Co., Inc.

Ref H2O-008

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 Number0841436101TD201B3NR Basic UDI-DI 10841436114971UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10841436114971 UDI-DI Date19 Jun 2019ListedStatusListed 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  • Withdrawn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
envision Transducer Cover
Generic Name
Body-surface ultrasound imaging transducer cover
Device Name
Gel-Free Covers (cover sterile)
Model / Ref / Catalog
H2O-008, H2O-008-5
Primary DI / UDI-DI
10841436114971
Basic UDI-DI
0841436101TD201B3NR
510(k) Number
FDA Product Code
ITX
EMDN Code
T030102 Cover sheaths, instruments and equipments
GMDN Term
Body-surface ultrasound imaging transducer cover
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Width — 24 Inch
Length — 5.5 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
H2O-008
GUDID
H2O-008, H2O-008-5
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Body-surface ultrasound imaging transducer cover

Cleared under the same submission (K190802)

Show all (12)

Other devices from Civco Medical Instruments Co., Inc.

See all devices from Civco Medical Instruments Co., Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No