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AMT MiniSPC Drainage Set

by Applied Medical Technology, Inc.

Ref ES1-1221

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 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/MDR EUDAMED Number08420711DRAINAGESET4Y Basic UDI-DI 00842071153045UDI-DIDate17 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842071153045 UDI-DI Date28 Apr 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 22 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  • Withdrawn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

Generic Name
Suprapubic drainage catheter
Device Name
MiniSPC Drainage Set
Model / Ref / Catalog
ES1-1221, S1-1221
Primary DI / UDI-DI
00842071153045
Basic UDI-DI
08420711DRAINAGESET4Y
510(k) Number
FDA Product Code
KOB, KNT
EMDN Code
U040199 Devices for suprapubic urinary drainage - other
GMDN Term
Suprapubic drainage catheter
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5090, 876.5980
Market of Registration
Denmark
GUDID distribution status
In Commercial Distribution
Size
Length — 12 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000041414
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Applied Medical Technology, Inc.

See all devices from Applied Medical Technology, Inc. →

Properties

  • Sterile
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • 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