Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Opera II — Class I MDR by MediMattress Ltd

MD Atlas
MediMattress Ltd

EUDAMED last updated this device on Dec 29, 2023

Opera II

6429810591OP2CW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MediMattress Ltd
UDI-DI code: 06430079689044
Reference / catalog number: OP2FECG1X00T00X

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

CaseClinic642981059120CCLSLOn the market CaseSlow642981059120CSLU4On the market CaseSupport642981059120CSUUNOn the market CaseTop642981059120CTOUDOn the market Eko3642981059110EK3RTOn 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.

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 II
UDI-DI code: 06430079689044
Basic UDI-DI: 6429810591OP2CW
Reference / catalog number: OP2FECG1X00T00X
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 II-FI-E-50x(110+70)x8
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 180 MU10
50 MU10
8 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