Nebulizer kit
by Hangzhou Formed Medical Devices Co., Ltd. 13 variants
Part of a family of 13 devices: see the family page
Ref PA0612
Nebulizer kit (PA0612) is a Class IIa device made by Hangzhou Formed Medical Devices Co., Ltd., registered in EUDAMED on 16 Mar 2026 (Basic UDI-DI 69233109PA06M2), active as of 24 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69233109PA06M2 06923310901437 | Date16 Mar 2026 | StatusActive |
Official records
- EUDAMED public site 69233109PA06M2
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- PA0612
- Primary DI / UDI-DI
- 06923310901437
- Basic UDI-DI
- 69233109PA06M2
- EMDN code
- R03010301 Aerosol therapy masks
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011212
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Similar devices in this category
Other devices filed under AEROSOL THERAPY MASKS.
- Nebulizer Mask XL7 by FEELLIFE HEALTH INC.
- OxyMulti-Mask™ OPHH-1025-8 by Southmedic Incorporated
- OxyMulti-Mask™ OHH-1025-8S by Southmedic Incorporated
- Aerogen® Go DP-M002 by HCMED INNOVATIONS CO., LTD.
- AEROSOL MASK, ADULT OM-82110 by BESMED HEALTH BUSINESS CORP.
- FACE TENT WITH AEROSOL 22mm CONNECTOR OM-81312 by BESMED HEALTH BUSINESS CORP.
- Paediatric Aerosol Face Mask 032-10-010U by FLEXICARE MEDICAL LIMITED
- APOSAN NE040K by Zhejiang Yuantong Medical Appliances Co., Ltd.
- nebulizer mask-s HAI14-E by JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD.
- Medical Nebulizers XL, L, M, S by Zhejiang Yuantong Medical Appliances Co., Ltd.
Other devices from Hangzhou Formed Medical Devices Co., Ltd.
See all devices from Hangzhou Formed Medical Devices Co., Ltd. →