Identity
- Trade Name
- Breezing Med EUDAMED
- Device Name
- Breezing Med EUDAMED
- Model / Reference
- B2018 EUDAMED601intern EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860005590209 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 (1)
- EUDAMED 377dadbb-bdc4-42f9-bbec-2fd5d6b73346 61 fields · synced Jun 18, 2026