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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

9553A — Class I MDD by Oy Fluorplast Ab

MD Atlas
Oy Fluorplast Ab

EUDAMED last updated this device on Apr 5, 2024

9553A

B-06430033408094

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Oy Fluorplast Ab
UDI-DI code: 06430033408094
Reference / catalog number: 9553A

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Manufacturer information

Organization name: Oy Fluorplast Ab
SRN: FI-MF-000015708
Manufacturer status: Active

Related devices

9360B-06430033406601On the market 9546B-06430033409466On the market 9387B-06430033406878On the market 9462B-06430033404379On the market 9313B-06430033406137On 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

2 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 2 countries total.

Country	On market since	Until
FinlandPrimary placement		Still on market
Estonia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 06430033408094
Basic UDI-DI: B-06430033408094
Reference / catalog number: 9553A
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC 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)

T030199COVERS, INSTRUMENTS AND 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification