Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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.

Organization name
UDI-DI code
Reference / catalog number

Dentipur Premium — Class I MDD by Helago-Pharma GmbH &…

MD Atlas
Helago-Pharma GmbH & Co. KG

EUDAMED last updated this device on Apr 23, 2026

Dentipur Premium

B-34002033002478

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Helago-Pharma GmbH & Co. KG
UDI-DI code: 34002033002478
Reference / catalog number: 900247

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?

Manufacturer information

Organization name: Helago-Pharma GmbH & Co. KG
SRN: DE-MF-000004933
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Do not use if you are hypersensitive to any of the ingredients.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: Dentipur Premium
UDI-DI code: 34002033002478
Basic UDI-DI: B-34002033002478
Reference / catalog number: 900247
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://helago-pharma.de/produkte/dentipur/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010280PROSTHETIC DENTISTRY DEVICES - ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

900327B-34002033003277On the market 900331B-34002033003314On the market Casino Crème fixativeB-34002033002836On the market 900282B-34002033002829On the market 900302B-34002033003024On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.