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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

ER4H FirstAid Web — Class IIb MDR by Dedalus Italia SpA

MD Atlas
Dedalus Italia SpA

EUDAMED last updated this device on May 13, 2026

ER4H FirstAid Web

805572803ER4HDK

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dedalus Italia SpA
UDI-DI code: 08055728030862
Reference / catalog number: ER4H FirstAid Web

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View device family (Basic UDI)

Manufacturer information

Organization name: Dedalus Italia SpA
SRN: IT-MF-000009127
Manufacturer status: Active

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Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jul 31, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08055728030862
Basic UDI-DI: 805572803ER4HDK
Reference / catalog number: ER4H FirstAid Web
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: —
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)08055728030862

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EMDN nomenclature code(s)

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

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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.