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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

Opera I — Class I MDR by MediMattress Ltd

MD Atlas
MediMattress Ltd

EUDAMED last updated this device on Dec 29, 2023

Opera I

6429810591OP1CU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MediMattress Ltd
UDI-DI code: 06430079689037
Reference / catalog number: OP1FECG1X00S00X

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Manufacturer information

Organization name: MediMattress Ltd
SRN: FI-MF-000009089
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: Opera I
UDI-DI code: 06430079689037
Basic UDI-DI: 6429810591OP1CU
Reference / catalog number: OP1FECG1X00S00X
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: Opera I-FI-E-50x(110+70)x8
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 8 MU10
50 MU10
180 MU10

EMDN nomenclature code(s)

V080701ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.