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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

PROD CS 9 — Class I MDD by PRODCONFARM SRL

MD Atlas
PRODCONFARM SRL

EUDAMED last updated this device on Jan 31, 2022

PROD CS 9

B-ROMF000017975PRODCS9NC

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PRODCONFARM SRL
UDI-DI code: D-ROMF000017975PRODCS9NC
Reference / catalog number: PROD CS 9

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View device family (Basic UDI)

Manufacturer information

Organization name: PRODCONFARM SRL
SRN: RO-MF-000017975
Manufacturer status: Active

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PRODT045944759041PRODT045ZOn the market PRODT035944759041PRODT035XOn the market PRODF0110105944759041PRODF0110105COn the market PRODT015944759041PRODT015TOn the market PRODF0310105944759041PRODF03101062On 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

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

CW009
Single use only
CW001
Not to be re-sterilized
CW007
Do not use if the package is damaged. Sterile content with unaffected pack
CW032
Inspect the envelope for the expiry date of the product

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Market distribution

Primary placement in Romania; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: D-ROMF000017975PRODCS9NC
Basic UDI-DI: B-ROMF000017975PRODCS9NC
Reference / catalog number: PROD CS 9
Issuing entity: EUDAMED

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: STERILE GAUZE COMPRESSES 27 cm / 27 cm COMPRESE STERILE DIN TIFON 27 cm / 27 cm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

M0201050101COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE

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

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