Crushield, Maxcrush
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Crushield, Maxcrush EUDAMEDCrushield FDA UDI
- Generic Name
- Pill crusher/splitter FDA UDI
- Device Name
- pill crusher pouch EUDAMEDCrushield pill crusher pouch, zip seal with tear top, 500/pkg. FDA UDI
- Model / Reference
- PE-R，HD-R，HD-C，HD-Z EUDAMEDBCB2803, BCB2804, BCSP01, BCSP02 EUDAMEDBCSP02 FDA UDI
- Description
- Crushield pill crusher pouch, zip seal with tear top, 500/pkg. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852359007373 EUDAMEDFDA UDI
- Basic UDI-DI
- 0852359007PP23YL EUDAMED
- FDA Product Code
- KYW 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Crushield, Maxcrush by Maxpert Medical 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
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0852359007PP23YL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Maxpert Medical LLC.
- EUDAMED SRN
- US-MF-000035311
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED f20659a4-a513-4876-a585-c8810fdb192b 61 fields · synced Jul 21, 2026
- FDA UDI 4e327220-0053-4fc0-99f3-95152076f21f 34 fields · synced May 30, 2026
- EUDAMED f20659a4-a513-4876-a585-c8810fdb192b-1 61 fields · synced Jun 10, 2026