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Swoop Transmit and Receive Radio Frequency Head Coil v2.2

by Hyperfine Operations, Inc.

Ref 815-11148-01Model 850-11001-06 (900-11001-06, in crate)

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 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850043319184 UDI-DI Date4 Dec 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0860000606100001R3 Basic UDI-DI 00850043319184UDI-DIDate8 Jan 2025RegisteredStatusActive

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 25 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  • Withdrawn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
Swoop Transmit and Receive Radio Frequency Head Coil
Generic Name
MRI system coil, radio-frequency
Device Name
Swoop® Portable MR Imaging® System
Model / Ref / Catalog
850-11001-06 (900-11001-06 EUDAMED
in crate) EUDAMED
815-11148-01 EUDAMED
v2.2 GUDID
900-11015-01 GUDID
Primary DI / UDI-DI
00850043319184
Basic UDI-DI
0860000606100001R3
510(k) Number
FDA Product Code
MOS
EMDN Code
Z1105018002 Magnetic resonance (MR) radiofrequency volumetric coils
GMDN Term
MRI system coil, radio-frequency
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1000
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
850-11001-06 (900-11001-06, in crate)
815-11148-01
GUDID
v2.2
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Hyperfine Operations, Inc.

Properties

  • Prescription Use
  • Serial Number

Other properties (22)

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