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Organization name
UDI-DI code
Reference / catalog number

TU-000-80 — Class IIa MDD by INFOMED SA

MD Atlas
INFOMED SA

EUDAMED last updated this device on Apr 23, 2024

TU-000-80

B-07640137441319

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: INFOMED SA
UDI-DI code: 07640137441319
Reference / catalog number: TU-000-80

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Manufacturer information

Organization name: INFOMED SA
SRN: CH-MF-000021686
Manufacturer status: Active

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
CW265
DEHP
CW001
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
EL		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07640137441319
Basic UDI-DI: B-07640137441319
Reference / catalog number: TU-000-80
Issuing entity: GS1

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: Vented spike
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

F020180ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - ACCESSORIES

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

DM-850-00B-07640137442767On the market KD-170-00B-07640137442446On the market LF-030-00B-07640137441043On the market LF-050-00B-07640137442842On the market LF-050-00B-07640137441050On 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.