Identity
- Trade Name
- RxCrush EUDAMEDFDA UDI
- Generic Name
- Pill crusher/splitter FDA UDI
- Device Name
- Pill Crusher EUDAMEDRxCrush Pill Crusher - English. 2-Stage Pill Crusher to crush and pulverize pills. FDA UDI
- Model / Reference
- PC11 EUDAMEDPC11-EN FDA UDI
- Description
- RxCrush Pill Crusher - English. 2-Stage Pill Crusher to crush and pulverize pills. FDA UDI
Identifiers
- Catalog Number
- PC11 FDA UDI
- Primary DI / UDI-DI
- 00850006611034 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850006611PC7J EUDAMED
- Direct Marketing DI
- 00850006611034 EUDAMED
- FDA Product Code
- OHY FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Pill crusher/splitter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6430 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Device sterilization/disinfection container, reusable
RxCrush by Resolve Designs LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0850006611PC7J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Resolve Designs LLC
- EUDAMED SRN
- US-MF-000017382
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED a9beea01-eb91-4525-b665-3ed940223423 61 fields · synced Jun 8, 2026
- FDA UDI 23cece00-83e7-4fb5-9b2e-35d8c201c083 36 fields · synced May 30, 2026