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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

FIXA STATIS — Class I MDR by ACIME FRAME

MD Atlas
ACIME FRAME

EUDAMED last updated this device on May 3, 2022

FIXA STATIS

376036546FIXA-STD-NIPX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ACIME FRAME
UDI-DI code: 03760365460068
Reference / catalog number: FIXA006

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Manufacturer information

Organization name: ACIME FRAME
SRN: FR-MF-000016067
Manufacturer status: Active

Related devices

AKU VUE376036546FUSI-STD-AC2GOn the market ALCYONE 3376036546SKIF-STD-NIWJOn the market AMBU FUSION +376036546FUSI-STD-AC2GOn the market AMBU FUSION 2376036546FUSI-STD-AC2GOn the market AMBU FUSION A376036546FUSI-STD-AC2GOn 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 France; available across 1 country total.

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

Device identification

Trade name: FIXA STATIS
UDI-DI code: 03760365460068
Basic UDI-DI: 376036546FIXA-STD-NIPX
Reference / catalog number: FIXA006
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.

EMDN nomenclature code(s)

V080603TREATMENT, DIAGNOSIS AND MONITORING MEDICAL BEDS

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
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Software identification