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

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Organization name
UDI-DI code
Reference / catalog number

Oravine 40g — Class I MDD by Helago-Pharma GmbH &…

MD Atlas
Helago-Pharma GmbH & Co. KG

EUDAMED last updated this device on Apr 30, 2026

Oravine 40g

B-34002033007510

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Helago-Pharma GmbH & Co. KG
UDI-DI code: 34002033007510
Reference / catalog number: 900751

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Manufacturer information

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

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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.

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: Oravine 40g
UDI-DI code: 34002033007510
Basic UDI-DI: B-34002033007510
Reference / catalog number: 900751
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/
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