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Disposable Breathing Filter
EUDAMEDClass IIa (EU MDR)
Ref HEPA-01Model HMEFRef BVF-03Model BVFRef BVF-01Ref BVF-04Ref BVF-02Ref BVF-08Ref HMEF-06Ref HMEF-05Ref BVF-05Ref HME-04Ref HEPA-02Ref HME-01Ref BVF-07Ref HEPA-03Ref HME-02Ref HMEF-04Ref HMEF-01Ref HMEF-03
Identity
- Trade Name
- Disposable Breathing Filter EUDAMED
- Device Name
- Disposable Breathing Filter EUDAMED
- Model / Reference
- HMEF EUDAMEDHEPA-01 EUDAMEDBVF EUDAMEDBVF-03 EUDAMEDBVF-01 EUDAMEDBVF-04 EUDAMEDBVF-02 EUDAMEDBVF-08 EUDAMEDHMEF-06 EUDAMEDHMEF-05 EUDAMEDBVF-05 EUDAMEDHME-04 EUDAMEDHEPA-02 EUDAMEDHME-01 EUDAMEDBVF-07 EUDAMEDHEPA-03 EUDAMEDHME-02 EUDAMEDHMEF-04 EUDAMEDHMEF-01 EUDAMEDHMEF-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970531332158 EUDAMED16970531332035 EUDAMED06970531332014 EUDAMED06970531332045 EUDAMED16970531332028 EUDAMED06970531332038 EUDAMED26970531332087 EUDAMED16970531332141 EUDAMED16970531332134 EUDAMED16970531332059 EUDAMED26970531332049 EUDAMED06970531332212 EUDAMED06970531332052 EUDAMED16970531332165 EUDAMED16970531332189 EUDAMED06970531332076 EUDAMED26970531332032 EUDAMED06970531332175 EUDAMED06970531332199 EUDAMED06970531332021 EUDAMED06970531332120 EUDAMED06970531332144 EUDAMED06970531332182 EUDAMED06970531332090 EUDAMED16970531332196 EUDAMED26970531332117 EUDAMED26970531332018 EUDAMED26970531332124 EUDAMED16970531332172 EUDAMED06970531332083 EUDAMED16970531332042 EUDAMED
- Basic UDI-DI
- 697053133hbfVX EUDAMED697053133dbfVB EUDAMED
- Direct Marketing DI
- 16970531332158 EUDAMED16970531332035 EUDAMED06970531332014 EUDAMED06970531332045 EUDAMED16970531332028 EUDAMED06970531332038 EUDAMED26970531332087 EUDAMED16970531332141 EUDAMED16970531332134 EUDAMED16970531332059 EUDAMED26970531332049 EUDAMED06970531332212 EUDAMED06970531332052 EUDAMED16970531332165 EUDAMED16970531332189 EUDAMED06970531332076 EUDAMED26970531332032 EUDAMED06970531332175 EUDAMED06970531332199 EUDAMED06970531332021 EUDAMED06970531332120 EUDAMED06970531332144 EUDAMED06970531332182 EUDAMED06970531332090 EUDAMED16970531332196 EUDAMED26970531332117 EUDAMED26970531332018 EUDAMED26970531332124 EUDAMED16970531332172 EUDAMED06970531332083 EUDAMED16970531332042 EUDAMED
- EMDN Code
- R0499 RESPIRATORY FILTERS - OTHER EUDAMEDR040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Breathing Filter by Shaoxing Undis Medical Technology 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 | 697053133hbfVX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shaoxing Undis Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000002187
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (31)
- EUDAMED 77eb3f76-75d1-4666-b4e8-047b3f62f4f7 61 fields · synced Oct 7, 2026
- EUDAMED feda917d-715d-43e4-83db-8c42a7dbb116 61 fields · synced May 11, 2026
- EUDAMED 12089489-23eb-40f0-8d35-3367df4e6b85 61 fields · synced May 11, 2026
- EUDAMED e78b99e9-fb70-4b37-9674-3e8552fe55fa 61 fields · synced May 16, 2026
- EUDAMED 860376fb-b24c-408d-81d5-c8df907a20a1 61 fields · synced May 16, 2026
- EUDAMED ae117de5-217b-4ff7-bb68-cc4c68423c3f 61 fields · synced May 16, 2026
- EUDAMED 4063b0cc-8461-416d-bdc6-6f5bea3553aa 61 fields · synced May 16, 2026
- EUDAMED 3552434d-4ac1-4af1-855f-ae3c0e7725ed 61 fields · synced May 17, 2026
- EUDAMED 9e305b6f-9f83-40e4-82b4-80aa75466872 61 fields · synced May 17, 2026
- EUDAMED 74315238-c7da-467d-9148-a33ea0d3c7be 61 fields · synced May 17, 2026
- EUDAMED 445753cf-2666-4adc-a84a-e572a57ecc05 61 fields · synced May 17, 2026
- EUDAMED 509ca252-9a57-4442-8846-1ae750ee2612 61 fields · synced May 17, 2026
- EUDAMED c6877fe7-845c-4b5c-9e0c-61d26e27be3e 61 fields · synced May 17, 2026
- EUDAMED c46b07b7-de53-4c20-90f0-ada0879ee694 61 fields · synced May 17, 2026
- EUDAMED c2b3eaa1-3668-4ace-82ac-050b542df013 61 fields · synced May 17, 2026
- EUDAMED 48897d70-bcf3-424d-95e7-c459020e7ac3 61 fields · synced May 17, 2026
- EUDAMED 000ff525-df26-423b-829f-0251f9a46bdc 61 fields · synced May 17, 2026
- EUDAMED a00197a0-12eb-40df-a0dc-1cc77519811d 61 fields · synced May 18, 2026
- EUDAMED e5bebf44-2a6e-4d44-9817-a7ebe71fcb71 61 fields · synced May 18, 2026
- EUDAMED e03bfaed-38b5-488e-b05c-f0e85a864d05 61 fields · synced May 19, 2026
- EUDAMED add6fa2c-f71b-49d2-a326-9b617b678a8b 61 fields · synced May 19, 2026
- EUDAMED 0bf3d37f-598c-4d22-8572-53c3a33c58bc 61 fields · synced May 19, 2026
- EUDAMED ec092e6f-74d1-4c7d-8ed7-9d5a48d2a9cc 61 fields · synced May 19, 2026
- EUDAMED c036e3e3-c0d8-4d55-bfaa-daebb043e32c 61 fields · synced May 19, 2026
- EUDAMED 45798780-296f-4851-b637-a9511fed82ef 61 fields · synced May 19, 2026
- EUDAMED 7d6894c5-6a7d-40be-8195-cff7e07cff2a 61 fields · synced May 19, 2026
- EUDAMED 8103c1a3-0a6f-46b7-9bb8-39209d4a3842 61 fields · synced May 19, 2026
- EUDAMED 3584af39-8fc7-45c3-9d22-2b2cfa74e497 61 fields · synced May 19, 2026
- EUDAMED e4defa3f-b303-483e-8c21-bc3f79108e42 61 fields · synced May 19, 2026
- EUDAMED 725a0d7f-c158-4d7c-927c-7ebaac36137e 61 fields · synced May 19, 2026
- EUDAMED 08418626-3766-48b7-9567-045a023fc1fd 61 fields · synced May 19, 2026