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Headgear

by Xiamen Compower Medical Tech. Co., Ltd. 2 variants

Ref ESH0101001Model CP611001、CP611002

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, self-declared

Class I: no certifier involved

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 Number06946430414229 UDI-DI Date18 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number694643043889515UF Basic UDI-DI Date5 Apr 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Headgear EUDAMED
Compower GUDID
Generic Name
Anaesthesia mask strap, single-use
Model / Reference
CP611001、CP611002 EUDAMED
ESH0101001 EUDAMED
CP611001 GUDID
Primary DI / UDI-DI
06946430414229, 06946430423320
Basic UDI-DI
694643043889515UF
FDA Product Code
BTK
EMDN Code
R9099, R9080
GMDN Term
Anaesthesia mask strap, single-use
Device Class
Class I
Regulation Number
868.5560
EU market of registration
Italy
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
CP611001、CP611002
ESH0101001
GUDID
CP611001

Manufacturer details

EUDAMED SRN
CN-MF-000011703
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Related devices

Category: Pulmonary function analysis system, adult

Other devices from Xiamen Compower Medical Tech. Co., Ltd.

See all devices from Xiamen Compower Medical Tech. Co., Ltd. →

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No