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SPIDERVIEW Pouch

by Microport Crm SRL

Ref RG008Model Holter bags

SPIDERVIEW Pouch is a device classified as Class I in the EU and Class II in the US made by Microport Crm SRL, registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI 8031527HOLTERBAGS000001LJ) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 08031527015149), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8031527HOLTERBAGS000001LJ Basic UDI-DI 08031527015149UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08031527015149 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8031527HOLTERBAGS000001LJ registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 08031527015149 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08031527015149
  2. Registered EUDAMED 8031527HOLTERBAGS000001LJ

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  • Withdrawn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
SpiderView disposable bag EUDAMED
Spiderview GUDID
Generic name
Electrocardiographic ambulatory recorder
Device name
Holter bags
Model / reference
Holter bags EUDAMED
RG008 EUDAMED
Pouch GUDID
Primary DI / UDI-DI
08031527015149
Basic UDI-DI
8031527HOLTERBAGS000001LJ
FDA product code
MWJ
EMDN code
Z12050403 ECG holter recorders
GMDN term
Electrocardiographic ambulatory recorder
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2800
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Holter bags
RG008
GUDID
Pouch
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrocardiographic ambulatory recorder

Similar devices in this category

Other devices filed under ECG HOLTER RECORDERS.

Other devices from Microport Crm SRL

See all devices from Microport Crm SRL →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)