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DuploSpray MIS

by Micromedics, Inc. 8 variants

Ref 0601133

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

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/MDD EUDAMED NumberB-10815634020570 Basic UDI-DI Date6 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10815634020570 UDI-DI Date15 Jun 2018ListedStatusListed GUDID: not 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
DuploSpray MIS EUDAMED
DuploSpray EUDAMEDGUDID
Generic Name
Open-surgery adhesive/sealant applicator, dual-channel
Model / Reference
0601133
Primary DI / UDI-DI
10815634020570, 00815634020573, 20815634020577
Basic UDI-DI
B-10815634020570, B-00815634020573, B-20815634020577
510(k) Number
FDA Product Code
FMF
EMDN Code
A020199 Syringes, single-use - other
GMDN Term
Open-surgery adhesive/sealant applicator, dual-channel
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5860
EU market of registration
Belgium
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000018365
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Micromedics, Inc.

See all devices from Micromedics, Inc. →

Properties

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

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Manufacturing Date: No