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Organization name
UDI-DI code
Reference / catalog number

Healsea Rescue — Class IIa MDR by Lallemand Pharma

MD Atlas
Lallemand Pharma

EUDAMED last updated this device on Oct 17, 2025

Healsea Rescue

76401497215RT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lallemand Pharma
UDI-DI code: 07640149724264
Reference / catalog number: 75015DJNF, 75015DJNJ, 75015DJNE

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Manufacturer information

Organization name: Lallemand Pharma
SRN: CH-MF-000036587
Manufacturer status: Active

Critical warnings

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

CW999
Do not use in children and adolescents under 18 years of age.
CW999
Do not use in case of hypersensitivity or allergy to one or several components.
CW999
Do not use with concomitant nasal product/drug at the same moment as the device.

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	Jan 1, 2026	Still on market
Poland	Dec 1, 2026	Still on market

Device identification

Trade name: Healsea Rescue
UDI-DI code: 07640149724264
Basic UDI-DI: 76401497215RT
Reference / catalog number: 75015DJNF, 75015DJNJ, 75015DJNE
Issuing entity: GS1

Classification

Risk category: Class IIa
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.

EMDN nomenclature code(s)

Q030103NASAL IRRIGATION SOLUTIONS

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

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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.