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Breezing Med
EUDAMEDClass I (EU MDR)
Ref 602internModel B2018Ref 603internRef 604intern
Identity
- Trade Name
- Breezing Med EUDAMED
- Device Name
- Breezing Med EUDAMED
- Model / Reference
- B2018 EUDAMED602intern EUDAMED603intern EUDAMED604intern EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860005590230 EUDAMED00860005590216 EUDAMED00860005590223 EUDAMED
- Basic UDI-DI
- 8600055902092010255A EUDAMED
- EMDN Code
- Z1203020404 METABOLISM EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Breezing Med by TF Health Corp — Class I — 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 | 8600055902092010255A | Class I | Active |
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Manufacturer
- Manufacturer
- TF Health Corp
- EUDAMED SRN
- US-MF-000043628
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (3)
- EUDAMED 7a06d351-5714-4a8f-a59b-65b9a0f690b6 61 fields · synced Jul 29, 2026
- EUDAMED c2856273-1fe6-4ea6-af44-fe1e41a302d8 61 fields · synced May 18, 2026
- EUDAMED 85b3d787-c5ad-405f-b165-c7185a47a143 61 fields · synced May 19, 2026