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Organization name
UDI-DI code
Reference / catalog number

CareMin650 ™ Oral Sleeve — Class I MDR by NEOMEDLIGHT

MD Atlas
NEOMEDLIGHT

EUDAMED last updated this device on May 4, 2026

CareMin650 ™ Oral Sleeve

376001257CM650Sleeve7A

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NEOMEDLIGHT
UDI-DI code: 03760012570034
Reference / catalog number: CM211

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Manufacturer information

Organization name: NEOMEDLIGHT
SRN: FR-MF-000004044
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Mar 26, 2021	Still on market

Device identification

Trade name: CareMin650 ™ Oral Sleeve
UDI-DI code: 03760012570034
Basic UDI-DI: 376001257CM650Sleeve7A
Reference / catalog number: CM211
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Le système de photothérapie CareMin650™ est destiné au traitement et/ou à la prévention des mucites et des dermites. Manchon de protection à usage unique enveloppant l'oral pad, 1 paire.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040285GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES

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

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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.