Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Bulkamid® Hydrogel — 1 UDI-DI variant, MDR (Contura International A/S)

MD Atlas
Contura International A/S

Data from EUDAMED, last updated May 31, 2026

Bulkamid® Hydrogel

5704101BulkamidCG

1 UDI-DI variant

MDR [Regulation (EU) 2017/745 on medical devices]Class IIb

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Manufacturer: Contura International A/S

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Device characteristics

Implantable

Clinical investigations

Registered: No

Registered: No

Investigation number: Investigational Device Exemption# G070144
Registered: No
Countries: Canada, United States

Legacy certificates

Certificate number: G70 003953 0006
Type: refdata.certificate-mdr-type.technical-documentation
Notified body: TÜV SÜD Product Service GmbH (0123)
Validity: Dec 5, 2024 → Nov 8, 2027

Identity & classification

Basic UDI-DI: 5704101BulkamidCG
Device name: Bulkamid® Hydrogel
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Jun 23, 2025

Manufacturer & authorised representative

Manufacturer

Name: Contura International A/S
SRN: DK-MF-000002018
Country: Denmark
Email: info@contura.com

Variants by status

UDI-DI variants

1 UDI-DI variant

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01JYEFSKQ4SJ3CNEEA0GX38RNF

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Bulkamid® Hydrogel05704101500098