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Leepak
EUDAMEDClass IIa (EU MDR)
Ref 135Model Sodium Chloride Inhalation Solution 0.9% w/v 5 MLRef 144Model Sodium Chloride Inhalation Solution 0.9% w/v 30 MLRef 143Model Sodium Chloride Inhalation Solution 0.9% w/v 25 MLRef 142Ref 64
Identity
- Trade Name
- LEEPAK EUDAMED
- Device Name
- Sodium Chloride Inhalation Solution 0.9% w/v EUDAMEDSodium Chloride Inhalation Solution 0.9% w/v 20ml EUDAMEDSodium Chloride Inhalation Solution 0.9% w/v 2.5ml EUDAMED
- Model / Reference
- Sodium Chloride Inhalation Solution 0.9% w/v 5 ML EUDAMED135 EUDAMEDSodium Chloride Inhalation Solution 0.9% w/v 30 ML EUDAMED144 EUDAMEDSodium Chloride Inhalation Solution 0.9% w/v 25 ML EUDAMED143 EUDAMED142 EUDAMED64 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G49913513 EUDAMEDG49914413 EUDAMEDG49914312 EUDAMEDD-salinesolotuion142K4 EUDAMEDD-salinesolution64VY EUDAMED
- Basic UDI-DI
- B-G49913513 EUDAMEDB-G49914413 EUDAMEDB-G49914312 EUDAMEDB-salinesolotuion142K4 EUDAMEDB-salinesolution64VY EUDAMED
- EMDN Code
- R060203 INHALATION THERAPY HUMIDIFICATION LIQUIDS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Leepak by Legency Remedies Pvt. Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-G49913513 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Legency Remedies Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000010030
- Authorised Representative
- Europecert UG (haftungsbeschränkt) DE-AR-000004974
Sources (5)
- EUDAMED 052eb420-d6e2-4129-a266-6f8fb4bfc594 61 fields · synced Oct 6, 2026
- EUDAMED 7d2e7edd-8a94-4b18-a176-844b69fc06b5 61 fields · synced May 17, 2026
- EUDAMED 7b2c922d-8a50-4eba-8a93-62774d0bd80b 61 fields · synced May 17, 2026
- EUDAMED 1e13bf5a-1001-428f-a824-04fa91226bed 61 fields · synced Jul 14, 2026
- EUDAMED af4a87b8-a67a-4000-9ba0-b46d5479372a 61 fields · synced Jul 17, 2026