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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

ADL-D138 — Class IIa MDD by ADL FARMACEUTICI SRL

MD Atlas
ADL FARMACEUTICI SRL

EUDAMED last updated this device on May 12, 2026

ADL-D138

B-08053306780604

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ADL FARMACEUTICI SRL
UDI-DI code: 08053306780604
Reference / catalog number: ADL-D138

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View device family (Basic UDI)

Manufacturer information

Organization name: ADL FARMACEUTICI SRL
SRN: IT-MF-000037063
Manufacturer status: Active

Critical warnings

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

CW010
Do not use in case of known hypersensitivity to one or more components. In case of adverse reactions suspend the use and consult a physician. Store at room temperature, out of heat sources. Keep out of reach of children. Do not use in case of hemorrhoids and rhagades, unless medical advice. Do not use in case of damaged package. Single use device: do not reuse in case of accidental releases. Risk of infections in case of reuse.

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Market distribution

Primary placement in Lithuania; available across 2 countries total.

Country	On market since	Until
LithuaniaPrimary placement	May 12, 2026	Still on market
Latvia	May 12, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08053306780604
Basic UDI-DI: B-08053306780604
Reference / catalog number: ADL-D138
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: Medicīniska ierīce 0425 Satur lielās ceļtekas (Plantago major) ekstraktu un nātrija hialuronātu. Macloren® supozitoriji ir medicīniska ierīce, kas satur lielās ceļtekas (Plantago major) ekstraktu un nātrija hialuronātu; tai ir nomierinoša un mīkstinoša iedarbība uz anālo kanālu. Supozitoriji paredzēti lokālai lietošanai sastrēguma prostatīta gadījumā, ko izraisa akūts vai hronisks prostatīts vai labdabīga prostatas hiperplāzija.
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)08053306780604

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EMDN nomenclature code(s)

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

U99DEVICES FOR UROGENITAL SYSTEM - 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

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Related devices

ADL-D128B-08053306780666On the market ADL-D23 CAMPB-08053306780680On the market ADL-D23B-08053306780673On the market ADL-D139CAMPB-08053306780659On the market ADL-D139B-08053306780734On 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.