Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

16.10.2026 19:20

Sync status

Successful

Device

4223198

Actor

48100

Certificate

3486

Filters

Show filters

Active filter:Certificate number:28620211491

3 device results listed.

Page 1 / 1

HYDRAFIL Procedure Kit

-

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: ReGelTec Inc.
Manufacturer SRN: US-MF-000025182
UDI-DI: 00195893334186
Basic UDI-DI: 0195893BM2022FG
Reference: 610-0003
EMDN: P09070201
EMDN description: DISC PROSTHESES
First on market country: -
Safety summary (SSCP/SSP): CE-2022-SSCP · Rev. 01
Authorised representative: Advena Limited
Last updated: 02.10.2026 17:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

HYDRAFIL Pressure Gauge

-

Class IIIMDR 2017/745No longer on the marketImplantableSingle useSterile

Manufacturer: ReGelTec Inc.
Manufacturer SRN: US-MF-000025182
UDI-DI: 00195893780129
Basic UDI-DI: 0195893BM2022FG
Reference: 610-0006
EMDN: P09070201
EMDN description: DISC PROSTHESES
First on market country: -
Safety summary (SSCP/SSP): CE-2022-SSCP · Rev. 01
Authorised representative: Advena Limited
Last updated: 25.09.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

HYDRAFIL Delivery System

610-0003

Class IIIMDR 2017/745No longer on the marketImplantableSingle useSterile

Manufacturer: ReGelTec Inc.
Manufacturer SRN: US-MF-000025182
UDI-DI: 00195893039395
Basic UDI-DI: 0195893BM2022FG
Reference: 610-0005
EMDN: P09070201
EMDN description: DISC PROSTHESES
First on market country: France
Safety summary (SSCP/SSP): CE-2022-SSCP · Rev. 01
Authorised representative: Advena Limited
Last updated: 25.09.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details