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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

PV11 — Class IIb MDD by Dima Italia S.r.l.

MD Atlas
Dima Italia S.r.l.

EUDAMED last updated this device on Apr 7, 2023

PV11

B-08058647920078

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Dima Italia S.r.l.
UDI-DI code: 08058647920078
Reference / catalog number: PV11

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View device family (Basic UDI)

Manufacturer information

Organization name: Dima Italia S.r.l.
SRN: IT-MF-000020327
Manufacturer status: Active

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BB RESPIRATORB-08058647920122On the market COR0000030B-08058647921082On the market COR0000040B-08058647921099On the market COR0000050B-08058647921105On the market COR0000060B-08058647921112On the market

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jan 17, 2019	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08058647920078
Basic UDI-DI: B-08058647920078
Reference / catalog number: PV11
Issuing entity: GS1

Classification

Risk category: Class IIb
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.

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.

R9099RESPIRATORY AND ANAESTHESIA 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.