Enterprise Tablet

by Urovo Healthcare Co., Ltd

Ref P8100HCModel P8100HC, P8100HC 5G, P8100HC Pro, P8100HC Lite, P8100H, P8100H 5G, P8100P (Healthcare), P8100 (Healthcare)

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	Number697608696TabletQ7 Basic UDI-DI 06976086960221UDI-DI	Date20 Apr 2026Registered	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Withdrawn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: Enterprise Tablet
Model / Reference: P8100HC, P8100HC 5G, P8100HC Pro, P8100HC Lite, P8100H, P8100H 5G, P8100P (Healthcare), P8100 (Healthcare)

Primary DI / UDI-DI: 06976086960221
Basic UDI-DI: 697608696TabletQ7
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-000053314
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

Other devices from Urovo Healthcare Co., Ltd

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