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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

OBPEN100 — Class I MDR by SALTEC TOMASZ KIRSZ

MD Atlas
SALTEC TOMASZ KIRSZ

EUDAMED last updated this device on Nov 23, 2023

OBPEN100

5906124322ochraniacze49

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SALTEC TOMASZ KIRSZ
UDI-DI code: 05906124322125
Reference / catalog number: OBPEN100

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View device family (Basic UDI)

Manufacturer information

Organization name: SALTEC TOMASZ KIRSZ
SRN: PL-MF-000038779
Manufacturer status: Active

Related devices

OBPEN100BH5906124322ochraniacze49On the market OBPEN100H5906124322ochraniacze49On the market OBPEN100B5906124322ochraniacze49On the market PW5010014ECO5906124322przescieradloENOn the market PW505014ECO5906124322przescieradloENOn 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.

CW009
EUDAMED did not publish a description for this code.

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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: 05906124322125
Basic UDI-DI: 5906124322ochraniacze49
Reference / catalog number: OBPEN100
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: 100
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

UDI-DI DataMatrix

Encoded

(01)05906124322125

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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.

T0208SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)

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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