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SPIDERVIEW 2 Leads / 5 E

by Microport Crm SRL

Part of a family of 10 devices: see the family page

Ref RC016Model ECG cables

SPIDERVIEW 2 Leads / 5 E 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 25 May 2026 (Basic UDI-DI 8031527ECGCABLES0000001E5) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 08031527015088), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8031527ECGCABLES0000001E5 Basic UDI-DI 08031527015088UDI-DIDate25 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08031527015088 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8031527ECGCABLES0000001E5 registered 25 May 2026 Active
  • FDA GUDID UDI-DI 08031527015088 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08031527015088
  2. Registered EUDAMED 8031527ECGCABLES0000001E5

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  • Withdrawn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
RC016 EUDAMED
Spiderview GUDID
Generic name
Electrocardiographic lead set, reusable
Model / reference
ECG cables EUDAMED
RC016 EUDAMED
2 Leads / 5 E GUDID
Primary DI / UDI-DI
08031527015088
Basic UDI-DI
8031527ECGCABLES0000001E5
FDA product code
MWJ
EMDN code
Z12050403 ECG holter recorders
GMDN term
Electrocardiographic lead set, reusable
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
ECG cables
RC016
GUDID
2 Leads / 5 E
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.

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)