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Apollo II
EUDAMEDClass I (EU MDR)
Ref DYN/DIG/APOLLO/2Model Apollo II dynamic systemRef APOLLO/2/CUSH/20Model Apollo II dynamic cushion (surface only)Ref APOLLO/2/CUSH/18
Identity
- Trade Name
- Apollo II EUDAMED
- Device Name
- Apollo II dynamic mattress system EUDAMEDApollo II dynamic cushion EUDAMED
- Model / Reference
- Apollo II dynamic system EUDAMEDDYN/DIG/APOLLO/2 EUDAMEDApollo II dynamic cushion (surface only) EUDAMEDAPOLLO/2/CUSH/20 EUDAMEDAPOLLO/2/CUSH/18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055785718379 EUDAMED05055785719321 EUDAMED05055785718492 EUDAMED
- Basic UDI-DI
- 50557857DPC011F9 EUDAMED50557857DPC004FC EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMEDV08030101 ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Apollo II by Drive DeVilbiss Healthcare Limited — 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 | 50557857DPC011F9 | Class I | Active |
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Manufacturer
- Manufacturer
- Drive DeVilbiss Healthcare Limited
- EUDAMED SRN
- GB-MF-000012818
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 712c7e8a-b178-4104-8456-ab77b0307b9e 61 fields · synced Oct 6, 2026
- EUDAMED 9f6d40b1-f857-4684-a2b7-42e2d5854518 61 fields · synced May 18, 2026
- EUDAMED 2d3022e8-a606-47e6-8c40-67b9cda941bc 61 fields · synced May 18, 2026