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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

REOXCARE HYDROGEL FOR DAMAGED SKIN — Class IIb MDD by histocell

MD Atlas
histocell

EUDAMED last updated this device on May 17, 2023

REOXCARE HYDROGEL FOR DAMAGED SKIN

B-18437015146024

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: histocell
UDI-DI code: 18437015146024
Reference / catalog number: SF099

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Manufacturer information

Organization name: histocell
SRN: ES-MF-000033503
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	May 9, 2016	Still on market

Device identification

Trade name: REOXCARE HYDROGEL FOR DAMAGED SKIN
UDI-DI code: 18437015146024
Basic UDI-DI: B-18437015146024
Reference / catalog number: SF099
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: [16:36] Almudena Rodríguez Mora Reoxcare Hidrogel para piel dañada es un producto sanitario clase IIb que consiste en un hidrogel amorfo utilizado para hidratar la herida.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M04040501HYDROGEL DRESSINGS, NON-COMBINED

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

REOXCARE Antioxidant wound dressingB-18437015146017On 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.