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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 10 — Class I MDD by PRODCONFARM SRL

MD Atlas
PRODCONFARM SRL

EUDAMED last updated this device on Jan 31, 2022

PROD CS 10

B-ROMF000017975PRODCS10HL

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PRODCONFARM SRL
UDI-DI code: D-ROMF000017975PRODCS10HL
Reference / catalog number: PROD CS 10

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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
Do not resterilize
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-ROMF000017975PRODCS10HL
Basic UDI-DI: B-ROMF000017975PRODCS10HL
Reference / catalog number: PROD CS 10
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 40 cm / 40 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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