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E-PP and E-PT

by GE Healthcare Finland Oy

Ref E-PP-00

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

CE MDR 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 Number8406821BUG00436HM Basic UDI-DI 00840682104159UDI-DIDate22 Aug 2024RegisteredStatusActive
European UnionCE/MDR EUDAMED Number8406821BUG00436HM Basic UDI-DI 00840682104159UDI-DIDate22 Aug 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682104159 UDI-DI Date21 Jun 2016ListedStatusListed 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  • Withdrawn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/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Patient monitoring system module, blood pressure, invasive
Device Name
E-PP and E-PT
E-Pp
Model / Reference
E-PP-00
Primary DI / UDI-DI
00840682104159
Basic UDI-DI
8406821BUG00436HM, B-00840682104159
510(k) Number
FDA Product Code
MHX
EMDN Code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN Term
Patient monitoring system module, blood pressure, invasive
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1025
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001176

Other devices from GE Healthcare Finland Oy

See all devices from GE Healthcare Finland Oy →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No