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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

AC 165 B DA 25 PZ. — Class I MDR by SA.GE srl

MD Atlas
SA.GE srl

EUDAMED last updated this device on Feb 15, 2023

AC 165 B DA 25 PZ.

805270596AC16525

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SA.GE srl
UDI-DI code: 18052705960133
Reference / catalog number: AC 165 B DA 25 PZ.

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View device family (Basic UDI)

Manufacturer information

Organization name: SA.GE srl
SRN: IT-MF-000030827
Manufacturer status: Active

Related devices

AC 165 B 100 PEZZI SFUSI805270596AC16525On the market AC 165 B DA 50 PZ805270596AC16525On the market AC 165 B CO 25 SCATOLE805270596AC16525On the market AC 150 B 800 PZ805270596AC150ZMOn the market AC 150 R DA 800805270596AC150ZMOn 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.

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 2 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Hungary		Still on market

Device identification

Trade name: not provided
UDI-DI code: 18052705960133
Basic UDI-DI: 805270596AC16525
Reference / catalog number: AC 165 B DA 25 PZ.
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 25
Additional product description: Premifistola blu, 25 pz
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 20.8 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)18052705960133

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

F9080DIALYSIS DEVICES - OTHER 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

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