Identity
- Trade Name
- Archimedes® System EUDAMEDArchimedes Planning System FDA UDI
- Generic Name
- Virtual bronchoscopic navigation PACS software FDA UDI
- Device Name
- Archimedes Planner EUDAMEDArchimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths on the computer or printed plan to the region of interest through both airways and lung tissue. FDA UDI
- Model / Reference
- 40009 EUDAMEDFDA UDI
- Description
- Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths on the computer or printed plan to the region of interest through both airways and lung tissue. FDA UDI
Identifiers
- Catalog Number
- 40009 FDA UDI
- Primary DI / UDI-DI
- 00856571007104 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00856571007104 EUDAMED
- 510(k) Number
- K133385 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- R0799 BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Virtual bronchoscopic navigation PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Archimedes® System by Broncus Medical Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00856571007104 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Broncus Medical, Inc.
- EUDAMED SRN
- US-MF-000027543
- Authorised Representative
- MedDevConsult GmbH DE-AR-000005877
Sources (2)
- EUDAMED f90c4f74-d28e-4eb1-93bd-d484cd9122fa 61 fields · synced Jun 19, 2026
- FDA UDI 3ad31311-afa5-4fe1-9a9b-11f7755f3b4d 37 fields · synced May 30, 2026