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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

Proctoscope — Class I MDR by SAPI MED S.p.A.

MD Atlas
SAPI MED S.p.A.

EUDAMED last updated this device on Mar 13, 2026

Proctoscope

803363880RCTSCSTVX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SAPI MED S.p.A.
UDI-DI code: 08033638803783
Reference / catalog number: A.4522LI

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View device family (Basic UDI)

Manufacturer information

Organization name: SAPI MED S.p.A.
SRN: IT-MF-000023733
Manufacturer status: Active

Related devices

ANOSCOPE803363880ANSCPB6On the market ANOSCOPE803363880ANSCPB6On the market A.4026ST803363880ANSCPSTPKOn the market A.4026803363880ANSCPB6On the market ANTROSOND803363880DRNGDYOn 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

1 warning recorded — scroll inside the panel to see all entries.

CW010
-

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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: Proctoscope
UDI-DI code: 08033638803783
Basic UDI-DI: 803363880RCTSCSTVX
Reference / catalog number: A.4522LI
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: —
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

UDI-DI DataMatrix

Encoded

(01)08033638803783

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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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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