EUDAMED last updated this device on Sep 3, 2026

Drenofast botella recambio 400 ml

8428097REDON63

On the marketClass IIa

Applicable legislation: —
Organization name: Iberhospitex, S.A.
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 →: 08428097023405
Reference / catalog number: 0028450

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.

Drenofast botella recambio 400 ml is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Iberhospitex, S.A.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Drenofast botella recambio 400 ml
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 →: 08428097023405
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 →: 8428097REDON63
Reference / catalog number: 0028450
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 IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: Drenofast 400 ml spare bottle
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 400 MU48

Packaging levels

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

08428097023405× 1 unitBase unit
- 08428097023412× 40 units

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08428097023405

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.

A0601010101DRAINAGE SYSTEMS WITH REDON TYPE RIGID CONTAINER

Critical warnings

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

Caution
Consult instructions for use
Do not re-use
Do not resterilize
Do not use if package is damaged

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Spain; available across 12 countries total.

Country	On market since	Until
SpainPrimary placement	—	Still on market
Austria	—	Still on market
Bulgaria	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
France	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Italy	—	Still on market
Netherlands	—	Still on market
Poland	—	Still on market
Slovakia	—	Still on market

Related searches

Class IIa medical devices in EUDAMED

Device identification

Trade name: Drenofast botella recambio 400 ml
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 →: 08428097023405
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 →: 8428097REDON63
Reference / catalog number: 0028450
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

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

2025 CR 0045Supplemented
Quality management system: CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS (0318)Expiry: Jul 1, 2029
2024 PR 0030Issued
Quality assurance: CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS (0318)Expiry: Jul 1, 2029
ES22/00000630Amended
Quality management system: SGS Belgium NV (1639)Expiry: Oct 10, 2027

Market distribution

Primary placement in Spain; available across 12 countries total.

Country	On market since	Until
SpainPrimary placement	—	Still on market
Austria	—	Still on market
Bulgaria	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
France	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Italy	—	Still on market
Netherlands	—	Still on market
Poland	—	Still on market
Slovakia	—	Still on market

Drenofast botella recambio 400 ml

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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