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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

70638 — Class III MDD by Rottapharm Ltd

MD Atlas
Rottapharm Ltd

EUDAMED last updated this device on Aug 17, 2023

70638

B-05391535660223

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Rottapharm Ltd
UDI-DI code: 05391535660223
Reference / catalog number: 70638

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Manufacturer information

Organization name: Rottapharm Ltd
SRN: IE-MF-000005490
Manufacturer status: Active

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70092B-05391535660032On the market 70093B-05391535660025On the market 70577B-05391535660209On the market 70267B-05391535660131On the market 70694B-05391535660261On 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.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Sep 1, 2000	Aug 17, 2023
France	Sep 1, 2000	Aug 17, 2023

Device identification

Trade name: not provided
UDI-DI code: 05391535660223
Basic UDI-DI: B-05391535660223
Reference / catalog number: 70638
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A02010799PREFILLED SYRINGES - OTHER

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