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

70216 — Class III MDD by Rottapharm Ltd

MD Atlas
Rottapharm Ltd

EUDAMED last updated this device on Aug 17, 2023

70216

B-05391535660100

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Rottapharm Ltd
UDI-DI code: 05391535660100
Reference / catalog number: 70216

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

Related devices

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

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: 05391535660100
Basic UDI-DI: B-05391535660100
Reference / catalog number: 70216
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

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.