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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

SPTE-ES46000 — Class I MDR by Medline International…

MD Atlas
Medline International France SAS

EUDAMED last updated this device on May 13, 2026

SPTE-ES46000

0884389DC141ANSGA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Medline International France SAS
UDI-DI code: 50884389964420
Reference / catalog number: SPTE-ES46000

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Manufacturer information

Organization name: Medline International France SAS
SRN: FR-MF-000000676
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

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

CW009
Do not re-use
CW011
Caution
CW999
Do not expose to a flame or high intensity heat sources

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 50884389964420
Basic UDI-DI: 0884389DC141ANSGA
Reference / catalog number: SPTE-ES46000
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: 12
Additional product description: DRAPE,ESS,TUR,FEN 5CM,LEG,FCP,280x242CM
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: DRAPE,ESS,TUR,FEN 5CM,LEG,FCP,280x242CM

EMDN nomenclature code(s)

T020199SURGICAL DRAPES - OTHER

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