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mesilife
EUDAMEDClass IIa (EU MDR)
Ref BR-KIT set childRef BR-SM153Ref BR-MN199
Identity
- Trade Name
- mesilife EUDAMED
- Device Name
- Non-sterile nebulizer accessory kit EUDAMEDPhlegm suction machine EUDAMEDMesh nebulizer EUDAMED
- Model / Reference
- BR-KIT set child EUDAMEDBR-SM153 EUDAMEDBR-MN199 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070911010 EUDAMED06975070911539 EUDAMED06975070911997 EUDAMED
- Basic UDI-DI
- 697507091NAKSM EUDAMED697507091SM37 EUDAMED697507091MN2P EUDAMED
- Direct Marketing DI
- 06975070911010 EUDAMED06975070911539 EUDAMED06975070911997 EUDAMED
- EMDN Code
- R03010380 AEROSOL THERAPY SYSTEMS - ACCESSORIES EUDAMEDR05010301 SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS EUDAMEDR060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
mesilife by ShenZhen Bi-rich Medical Devices Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697507091NAKSM | Class IIa | Active |
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Manufacturer
- Manufacturer
- ShenZhen Bi-rich Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000023061
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED 17ff4dd7-4df5-47a4-9867-d8082e35dc82 61 fields · synced Oct 6, 2026
- EUDAMED 561ffab0-f332-4bee-b348-4cde67471016 61 fields · synced May 17, 2026
- EUDAMED 8fb55304-f92f-4aa3-9d79-18e5c2cc36c7 61 fields · synced May 18, 2026
- EUDAMED f6555f49-af28-472b-b2d5-e9b0c1d9e614 61 fields · synced Jul 10, 2026
- EUDAMED 83f363b1-0021-4f9d-98d2-71dd02388406 61 fields · synced Jul 13, 2026