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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

SOFT (SPACE) IPM95 — Class I MDR by ZBIGNIEW FRĄCKOWIAK…

MD Atlas
ZBIGNIEW FRĄCKOWIAK MAZBIT PRZEDSIĘBIORSTWO

EUDAMED last updated this device on May 6, 2024

SOFT (SPACE) IPM95

59025742IORTO-PROSW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ZBIGNIEW FRĄCKOWIAK MAZBIT PRZEDSIĘBIORSTWO
UDI-DI code: 05902574212900
Reference / catalog number: SOFT (SPACE) IPM95

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Manufacturer information

Organization name: ZBIGNIEW FRĄCKOWIAK MAZBIT PRZEDSIĘBIORSTWO
SRN: PL-MF-000039173
Manufacturer status: Active

Related devices

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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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05902574212900
Basic UDI-DI: 59025742IORTO-PROSW
Reference / catalog number: SOFT (SPACE) IPM95
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: 1
Additional product description: SOFT (SPACE) roz. 41/42
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 41/42

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05902574212900

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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.

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

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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