Identity
- Trade Name
- Action® EUDAMEDFDA UDI
- Generic Name
- Radiation therapy bolus, reusable FDA UDI
- Device Name
- Bolx-II EUDAMED
- Model / Reference
- 32054030 EUDAMEDBolx II FDA UDI
Identifiers
- Catalog Number
- 32054030 FDA UDI
- Primary DI / UDI-DI
- 00089904007964 EUDAMEDFDA UDI
- Basic UDI-DI
- 008990411NJ EUDAMED
- 510(k) Number
- K811528 FDA UDI
- FDA Product Code
- JAD FDA UDI
- EMDN Code
- Z119085 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Radiation therapy bolus, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5900 FDA UDI
- Market of Registration
- Denmark 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
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
Prescription Use
No
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
No
FDA UDI
Action® by Action Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 008990411NJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Action Products, Inc.
- EUDAMED SRN
- US-MF-000008997
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 0e63ab8d-9a5e-49b3-b911-bab11484e55f 61 fields · synced Jun 9, 2026
- FDA UDI 41206f1e-2a4f-4e15-870d-14270e13b98d 35 fields · synced May 30, 2026