Skip to content

MiniSPC Button - Low Profile Suprapubic Catheter

by Applied Medical Technology, Inc. 35 variants

Ref SPC-1240-12

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 Number08420711MINISPCJV Basic UDI-DI 00842071152352UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842071152352 UDI-DI Date16 Mar 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  • Withdrawn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

Trade Name
MiniSPC Button - Low Profile Suprapubic Catheter EUDAMED
MiniSPC Button GUDID
Generic Name
Suprapubic drainage catheter
Model / Ref / Catalog
SPC-1240-12
Primary DI / UDI-DI
00842071152352
Basic UDI-DI
08420711MINISPCJV
510(k) Number
FDA Product Code
KOB, KNT
EMDN Code
U040102 Kits with drainage catheters and introducers
GMDN Term
Suprapubic drainage catheter
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5090, 876.5980
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Catheter Gauge — 12 French
Length — 4.0 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
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
  • 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