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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

P805 — Class I MDR by INNOW Spółka z…

MD Atlas
INNOW Spółka z ograniczoną odpowiedzialnością Spółka komandytowa

EUDAMED last updated this device on Feb 8, 2024

P805

590581741PARAWANY8U

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: INNOW Spółka z ograniczoną odpowiedzialnością Spółka komandytowa
UDI-DI code: 05905817411115
Reference / catalog number: P805

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View device family (Basic UDI)

Manufacturer information

Organization name: INNOW Spółka z ograniczoną odpowiedzialnością Spółka komandytowa
SRN: PL-MF-000032529
Manufacturer status: Active

Related devices

PQ900590581741PARAWANY8UOn the market P808590581741PARAWANY8UOn the market P804590581741PARAWANY8UOn the market PQ805ST590581741PARAWANY8UOn the market PQ802590581741PARAWANY8UOn 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

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: 05905817411115
Basic UDI-DI: 590581741PARAWANY8U
Reference / catalog number: P805
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: —
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.

V0899MEDICAL SUPPORT EQUIPMENT - 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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