EUDAMED last updated this device on Aug 6, 2026

Smartex

8908004933SLEPP1JX

On the marketClass I

Applicable legislation: —
Organization name: St.Marys Rubbers Pvt. Ltd.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08904448605136
Reference / catalog number: 1LEPP-11L

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

Smartex is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by St.Marys Rubbers Pvt. Ltd.. Placed on the EU market in Greece. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Smartex
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08904448605136
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 8908004933SLEPP1JX
Reference / catalog number: 1LEPP-11L
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class I
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: STERILE LATEX EXAMINATION GLOVES PRE-POWDERED
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Packaging levels

2 packaging levels registered — each level carries its own UDI-DI.

08904448605136× 1 unitBase unit
- 18904448605133× 50 units
  - 28904448605130× 10 units

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08904448605136

UDI-PI DataMatrix

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

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

T010201LATEX EXAMINATION / TREATMENT GLOVES

Critical warnings

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

Caution
This product contains natural rubber latex which may cause allergic reactions including anaphylactic responses in some individuals. In case of latex allergy , discontinue the use and consult a physician.
Do not re-use
Risk of reuse : May cause infection, allergic reaction and poor barrier protection.
Do not resterilize
symbol
Do not sterilise
Sterile until package is opened or damaged

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in EL; available across 1 country total.

Country	On market since	Until
ELPrimary placement	Jan 1, 2026	Dec 31, 2030

Smartex

Device identification

Classification

Device details

Packaging levels

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Packaging levels

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Certificates covering this device

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