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nPLANE RAS UNILATERAL KIT - LEFT

by CranioMandibular Rehab, Inc.

Ref CR5710

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850056079495 UDI-DI Date9 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number850056079NPU7 Basic UDI-DI 00850056079495UDI-DIDate23 Jun 2026RegisteredStatusActive

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  • Withdrawn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
nPLANE RAS UNILATERAL KIT - LEFT EUDAMED
nPLANE GUDID
Generic Name
Intranasal splint, non-biodegradable
Device Name
Nasal Conformer
Model / Reference
CR5710
Primary DI / UDI-DI
00850056079495
Basic UDI-DI
850056079NPU7
Direct Marketing DI
00850056079495
FDA Product Code
EPP
EMDN Code
P020203 Nasal splints
GMDN Term
Intranasal splint, non-biodegradable
Device Class
Class I
Regulation Number
874.5800
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000039893
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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Properties

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