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.

Retainer-Reinigungstabletten Oramedix… — 1 UDI-DI variant, MDD

MD Atlas
Helago-Pharma GmbH & Co. KG

Data from EUDAMED, last updated May 31, 2026

Retainer-Reinigungstabletten Oramedix x128

B-34002033007169

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIb

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Manufacturer: Helago-Pharma GmbH & Co. KG

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

No device characteristics flagged

Legacy certificates

Certificate number: D1449500004
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: mdc medical device certification GmbH (0483)
Validity: Dec 31, 2028

Identity & classification

Basic UDI-DI: B-34002033007169
Device name: Retainer-Reinigungstabletten Oramedix x128
Device model: Retainer-Reinigungstabletten Oramedix x128
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Version date: May 28, 2026

Manufacturer & authorised representative

Manufacturer

Name: Helago-Pharma GmbH & Co. KG
SRN: DE-MF-000004933
Country: Germany
Email: qm@helago.de
Phone: +49 3871 6363 0

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

basicUdiUlid01KSPMR4RPE6ZDAMSXEKFW4T4Z

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

Retainer-Reinigungstabletten Oramedix x12834002033007169