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Pulmogine®
EUDAMEDClass IIa (EU MDR)
Ref DP-P001Ref HCM-860Ref DP-M001Ref HCM-86CRef DP-M002
Identity
- Trade Name
- Pulmogine® EUDAMED
- Device Name
- Mouthpiece EUDAMEDNebulizing Systems (including nebulizers, masks and mouthpieces) EUDAMEDAdult mask EUDAMEDPediatric mask EUDAMED
- Model / Reference
- DP-P001 EUDAMEDHCM-860 EUDAMEDDP-M001 EUDAMEDHCM-86C EUDAMEDDP-M002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873130405 EUDAMED04719873130009 EUDAMED04719873130122 EUDAMED04719873130382 EUDAMED04719873130085 EUDAMED04719873130399 EUDAMED04719873130139 EUDAMED04719873130146 EUDAMED
- Basic UDI-DI
- B-04719873130405 EUDAMEDB-04719873130009 EUDAMEDB-04719873130122 EUDAMEDB-04719873130382 EUDAMEDB-04719873130085 EUDAMEDB-04719873130399 EUDAMEDB-04719873130139 EUDAMEDB-04719873130146 EUDAMED
- EMDN Code
- R9001 RESPIRATORY MOUTHPIECES EUDAMEDR030180,R060101,R9001 EUDAMEDR030180 RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMEDR03010301 AEROSOL THERAPY MASKS EUDAMEDR03010301,R060101,R9001 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pulmogine® by Hcmed Innovations Co., 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-04719873130405 | Class IIa | Active |
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Manufacturer
- Manufacturer
- HCmed Innovations Co., Ltd.
- EUDAMED SRN
- TW-MF-000011348
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (13)
- EUDAMED df534641-519f-478e-90af-098394e3e097 61 fields · synced Aug 1, 2026
- EUDAMED 864644d4-aa05-4f16-bbf7-a8681faeae2d 61 fields · synced May 17, 2026
- EUDAMED d50955ea-17e8-43b2-afc1-d74f7d66356c 61 fields · synced May 17, 2026
- EUDAMED 1faa3b21-09e2-4e3f-aa85-f7f8992554ca 61 fields · synced May 17, 2026
- EUDAMED f550c591-0a53-4e10-88b1-e293d372f7da 61 fields · synced May 17, 2026
- EUDAMED 51134682-91cd-480b-b89f-4a3bda7b3887 61 fields · synced May 18, 2026
- EUDAMED 47f0ee09-3fa0-4163-bd79-cdc438d2fcc7 61 fields · synced Jul 11, 2026
- EUDAMED 21332c3c-c751-406a-b30f-b63c3e84a7e8 61 fields · synced Jul 14, 2026
- EUDAMED 0787c9eb-0491-4a06-81a3-cd692c8f71a2 61 fields · synced Jul 16, 2026
- EUDAMED ea83c360-e071-4371-a4a8-ea8b74b4aa25 61 fields · synced Jul 20, 2026
- EUDAMED 49d43c76-be04-408f-a713-e50cd4701134 61 fields · synced Jul 26, 2026
- EUDAMED a99b1e98-b019-4ed1-896c-710b7522e9db 61 fields · synced Jul 31, 2026
- EUDAMED 4d017f42-5a26-4a66-ba03-0ad7b6aedde7 61 fields · synced Aug 1, 2026