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Balmoral II
EUDAMEDClass IIa (EU MDR)
Ref Harvest Balmoral II Active MattressModel Balmoral II - EFFECT 4612
Identity
- Trade Name
- Balmoral II EUDAMED
- Device Name
- Balmoral II Active Mattress EUDAMED
- Model / Reference
- Balmoral II - EFFECT 4612 EUDAMEDHarvest Balmoral II Active Mattress EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972910603364 EUDAMED
- Basic UDI-DI
- B-06972910603364 EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Balmoral II by Airflo (Xiamen) Medical Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06972910603364 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Airflo (Xiamen) Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000008552
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 1d859533-e7f2-4102-a103-ed24aafcc9b6 61 fields · synced Jul 9, 2026