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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

800304 — Class I MDR by THD S.P.A.

MD Atlas
THD S.P.A.

EUDAMED last updated this device on Dec 11, 2023

800304

803373771DIANS0004Y7

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: THD S.P.A.
UDI-DI code: 08051887043156
Reference / catalog number: 800304

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View device family (Basic UDI)

Manufacturer information

Organization name: THD S.P.A.
SRN: IT-MF-000029427
Manufacturer status: Active

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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.

CW007
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.
CW011
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08051887043156
Basic UDI-DI: 803373771DIANS0004Y7
Reference / catalog number: 800304
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: THD N-ANO BASIC is an anoscope shaped so that it can be easily inserted into the anal canal. Each anoscope comes with a comfortable introducer. THD N-ANO BASIC is an anoscope that comes with an in-built lighting system in the handle which may consist of: 1) THD PEN-LIGHT USB (REF 880070): cold light LED cannula, reusable, powered by dedicated battery source THD LED SOURCE USB (REF 880063); 2) THD OPTI-FIBER (REVO/BT) (REF 880012): optical fibre with dedicated integrated tip for coupling with handle THD N-ANO BASIC, powered by a dedicated light source THD REVOLUTION (REF 700017) The operator can choose the desired lighting system, be it THD PEN-LIGHT USB with THD LED SOURCE USB (sales configuration of THD N-ANO BASIC and its variants), or coupling with THD OPTI-FIBER (REVO/BT
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.

G02060301ANOSCOPES

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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