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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

ZV-1670024-01 — Class IIb MDR by VULM s.r.o.

MD Atlas
VULM s.r.o.

EUDAMED last updated this device on May 27, 2026

ZV-1670024-01

8588006802Berovenal2Q

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VULM s.r.o.
UDI-DI code: 08588006802122
Reference / catalog number: ZV-1670024-01

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View device family (Basic UDI)

Manufacturer information

Organization name: VULM s.r.o.
SRN: SK-MF-000001981
Manufacturer status: Active

Critical warnings

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

CW011
Len na vonkajšie použitie v oblasti konečníka a nesmie sa používať vnútorne. Obsahuje konzervačné látky metylparabén a propylparabén.

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Market distribution

Primary placement in Slovakia; available across 1 country total.

Country	On market since	Until
SlovakiaPrimary placement	Feb 20, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08588006802122
Basic UDI-DI: 8588006802Berovenal2Q
Reference / catalog number: ZV-1670024-01
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Berovenal hydrogél na podporu liečby chronických rán a urýchlenie hojenia
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)08588006802122

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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.

M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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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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.