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Organization name
UDI-DI code
Reference / catalog number

CT Filling Set 120 cm — Class IIa MDD by Salofa Oy

MD Atlas
Salofa Oy

EUDAMED last updated this device on Dec 20, 2021

CT Filling Set 120 cm

B-FIMF16823CTFS120DRV4V

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Salofa Oy
UDI-DI code: D-FIMF16823CTFS120DRV4V
Reference / catalog number: CTFS120DRV

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Manufacturer information

Organization name: Salofa Oy
SRN: FI-MF-000016823
Manufacturer status: Active

Critical warnings

4 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.
CW032
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Nov 12, 2015	Still on market

Device identification

Trade name: CT Filling Set 120 cm
UDI-DI code: D-FIMF16823CTFS120DRV4V
Basic UDI-DI: B-FIMF16823CTFS120DRV4V
Reference / catalog number: CTFS120DRV
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
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: 120 MU20

EMDN nomenclature code(s)

A030499ADMINISTRATION KITS - 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

Related devices

CT Patient Line 120 cm (300 psi)B-FIMF16823CTPL120RVH8SOn the market CT Patient Line 20 cm (300 psi)B-FIMF16823CTPL020RVH8DOn the market CT Patient Line 40 cm (300 psi)B-FIMF16823CTPL040RVH93On the market CT Patient Line 40 cm (300 psi), 2 valvesB-FIMF16823CTPL040RV2H78On the market CT Patient Line 40 cm (300 psi), 2 valves, RAB-FIMF16823CTPL040RV2HRBCOn 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.