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Bone Cement Mixing System
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5050166Model CL006-01
Identity
- Trade Name
- Bone Cement Mixing System EUDAMEDPALABOWL FDA UDI
- Generic Name
- Manual orthopaedic cement mixer, single-use FDA UDI
- Device Name
- Bone Cement Mixing System EUDAMEDBone Cement Mixing System (Logo: PALABOWL)[Model No.:CL006-01) FDA UDI
- Model / Reference
- CL006-01 EUDAMED5050166 EUDAMEDCL006-01BE(CM194-2) FDA UDI
- Description
- Bone Cement Mixing System (Logo: PALABOWL)[Model No.:CL006-01) FDA UDI
Identifiers
- Catalog Number
- CL006-01BE(CM194-2) FDA UDI
- Primary DI / UDI-DI
- 06951233720897 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06951233720897 EUDAMED
- FDA Product Code
- JDZ FDA UDI
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
- GMDN Term
- Manual orthopaedic cement mixer, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4210 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Bone Cement Mixing System by Guangzhou Clean Medical Products Manufacturing Corp. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-06951233720897 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Guangzhou Clean Medical Products Manufacturing Corp.
- EUDAMED SRN
- CN-MF-000008926
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 99c4aae7-b92a-4406-90f9-11c29cf6e0af 61 fields · synced Oct 6, 2026
- FDA UDI 9096de5c-958f-4dfa-85e6-6dae278b3549 34 fields · synced May 29, 2026