Cold compress patch

by Shandong Ugel Bio-Tech Co., Ltd.

Ref 40mm*100mmModel 40mm*70mm.40mm*100mm.40mm*110mm.45mm*70mm.45mm*105mm.50mm*60mm.50mm*65mm.50mm*110mm.50mm*120mm.70mm*100mm.80mm*120mm.85mm*125mm.90mm*130mm.100mm*140mm.

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697119433CCPEU01NC Basic UDI-DI 06971194330560UDI-DI	Date18 Feb 2025Registered	StatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Cold compress patch
Model / Reference: 40mm*70mm.40mm*100mm.40mm*110mm.45mm*70mm.45mm*105mm.50mm*60mm.50mm*65mm.50mm*110mm.50mm*120mm.70mm*100mm.80mm*120mm.85mm*125mm.90mm*130mm.100mm*140mm., 40mm*100mm

Primary DI / UDI-DI: 06971194330560
Basic UDI-DI: 697119433CCPEU01NC
EMDN Code: V9099 Various devices not included in other classes - other

Device Class: Class I
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000043509
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

Other devices from Shandong Ugel Bio-Tech Co., Ltd.

Wound Plasters

Class I
Cooling Patch

Class I

Properties

Other properties (13)

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