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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

05615 — Class I MDD by Laboratorio Chimico…

MD Atlas
Laboratorio Chimico Farmaceutico A. Sella Srl

EUDAMED last updated this device on May 26, 2023

05615

B-08032632600510DZ

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Laboratorio Chimico Farmaceutico A. Sella Srl
UDI-DI code: D-08032632600510DZ
Reference / catalog number: 05615

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Manufacturer information

Organization name: Laboratorio Chimico Farmaceutico A. Sella Srl
SRN: IT-MF-000026481
Manufacturer status: Active

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW009
SYMBOL
CW010
SYMBOL/LEGGERE ATTENTAMENTE IL FOGLIO ILLUSTRATIVO/READ THE LEAFLET OF CHILDREN
CW011
SYMBOL
CW135
TENERE FUORI DALLA PORTATA DEI BAMBINI/KEEP OUT FROM THE REACH OF CHILDREN

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-08032632600510DZ
Basic UDI-DI: B-08032632600510DZ
Reference / catalog number: 05615
Issuing entity: EUDAMED

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: 12 SUPPOSITORIES
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

G99GASTROINTESTINAL DEVICES - 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

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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.