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Nellcor SC-A-I

by Covidien LP

Ref SC-A-I

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00008778R Basic UDI-DI 10884521091986UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521091986 UDI-DI Date25 May 2026ListedStatusListed 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 24 Oct 2026.

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  • Withdrawn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
Nellcor
Generic Name
Pulse oximeter probe, single-use
Device Name
OxySoft Neonatal-Adult SpO2 sensor
Model / Reference
SC-A-I
Primary DI / UDI-DI
10884521091986
Basic UDI-DI
0763000B00008778R
510(k) Number
FDA Product Code
DQA
EMDN Code
Z1203020408 Pulse oximeters
GMDN Term
Pulse oximeter probe, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.2700
EU market of registration
Netherlands
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

Related devices

Cleared under the same submission (K030930)

Other devices from Covidien LP

See all devices from Covidien LP →

Properties

  • Sterile
  • Single Use
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Serial Number: No
  • Manufacturing Date: No