Identity
- Trade Name
- Archimedes Dilation Balloon EUDAMEDFDA UDI
- Generic Name
- Bronchial balloon catheter FDA UDI
- Device Name
- Archimedes Balloon EUDAMEDA sterile single use flexible tube with a balloon at or near the distal tip that is inserted through the bronchoscope or sheath and used to dilate the target lung tissue of the bronchial tree. FDA UDI
- Model / Reference
- 10008 EUDAMEDFDA UDI
- Description
- A sterile single use flexible tube with a balloon at or near the distal tip that is inserted through the bronchoscope or sheath and used to dilate the target lung tissue of the bronchial tree. FDA UDI
Identifiers
- Catalog Number
- 10008 FDA UDI
- Primary DI / UDI-DI
- 00856571007074 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00856571007074 EUDAMED
- 510(k) Number
- K131234 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- EMDN Code
- R0799 BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Bronchial balloon catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.9 Millimeter FDA UDI
Archimedes Dilation Balloon 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-00856571007074 | 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 a8e62ab2-6055-4aa5-bb3f-f1d249ed612c 61 fields · synced Jul 26, 2026
- FDA UDI 1357f10b-a7e8-4c9f-a270-bedd2c841ce6 38 fields · synced May 30, 2026