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Archimedes® System
EUDAMEDClass IIa (EU MDR)
Ref 42105Model Archimedes Lite, 220-240V
Identity
- Trade Name
- Archimedes® System EUDAMED
- Device Name
- Archimedes Lite EUDAMED
- Model / Reference
- Archimedes Lite, 220-240V EUDAMED42105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00856571007289 EUDAMED
- Basic UDI-DI
- B-00856571007289 EUDAMED
- EMDN Code
- R0799 BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Netherlands 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
Archimedes® System by Broncus Medical Inc. — 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-00856571007289 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Broncus Medical, Inc.
- EUDAMED SRN
- US-MF-000027543
- Authorised Representative
- MedDevConsult GmbH DE-AR-000005877
Sources (1)
- EUDAMED 3cceb97a-7147-4444-a6fc-95c5ae686410 61 fields · synced Jun 19, 2026