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Stephen H Comfort Vers.2
EUDAMEDClass I (EU MDR)
Ref GB0004.-2Model Poltrone Hospital
Identity
- Trade Name
- Stephen H Comfort Vers.2 EUDAMED
- Model / Reference
- Poltrone Hospital EUDAMEDGB0004.-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057717403060 EUDAMED
- Basic UDI-DI
- 805771740POLPE EUDAMED
- Direct Marketing DI
- 08057717403060 EUDAMED
- EMDN Code
- V08020101 GENERIC USE ELECTRIC MEDICAL CHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Stephen H Comfort Vers.2 by Gardhen Bilance — 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 | 805771740POLPE | Class I | Active |
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Manufacturer
- Manufacturer
- Gardhen Bilance
- EUDAMED SRN
- IT-MF-000013019
Sources (1)
- EUDAMED 49dfde6b-728a-4c8a-a07b-4a46f98a9aa2 61 fields · synced Jun 19, 2026