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Piezo Respiratory Effort Sensor Kit - Abdomen for Embla / Key Connector

by S.L.P. Ltd.

Ref 1368-KitModel 13XX, 612XX series

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7290008986EF001VK Basic UDI-DI 07290012144325UDI-DIDate27 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07290012144325 UDI-DI Date20 Sep 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.

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  • Withdrawn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
Piezo Respiratory Effort Sensor Kit - Abdomen for Embla / Key Connector EUDAMED
Sleepsense GUDID
Generic Name
Polysomnography analyser
Device Name
Effort Sensors
Model / Reference
13XX, 612XX series, 1368-Kit
Primary DI / UDI-DI
07290012144325
Basic UDI-DI
7290008986EF001VK
EMDN Code
Z1399 Non-specific consumables for diagnostic instruments - other
GMDN Term
Polysomnography analyser
Device Class
Class I
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
IL-MF-000016600
Authorised representative
Arazy Group GmbH DE-AR-000007685

Other devices from S.L.P. Ltd.

See all devices from S.L.P. Ltd. →

Properties

  • Convenience Kit

Other properties (23)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No