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CopiOs Bone Void Filler - Sponge 10cc
EUDAMEDFDA UDIClass III (EU MDR)
Ref 00-1103-010-10Model CB00030
Identity
- Trade Name
- CopiOs Bone Void Filler - Sponge 10cc EUDAMEDCopiOs® Bone Void Filler Sponge FDA UDI
- Generic Name
- Bone matrix implant, composite FDA UDI
- Device Name
- CopiOs Bone Void Filler - Sponge EUDAMED
- Model / Reference
- CB00030 EUDAMED00-1103-010-10 EUDAMED20101-03 FDA UDI
Identifiers
- Catalog Number
- 00-1103-010-10 FDA UDI
- Primary DI / UDI-DI
- 00812337021067 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00812337021067 EUDAMED
- FDA Product Code
- MQV FDA UDI
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
- GMDN Term
- Bone matrix implant, composite FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
- Total Volume — 10 Milliliter FDA UDI
CopiOs Bone Void Filler - Sponge 10cc by Dsm Biomedical, Inc. — Class III — 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-00812337021067 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- DSM Biomedical, Inc.
- EUDAMED SRN
- US-MF-000021393
- Authorised Representative
- DSM Biomedical B.V. NL-AR-000018633
Sources (2)
- EUDAMED 93d8d128-6923-429f-a357-7065693f76b3 61 fields · synced Jul 15, 2026
- FDA UDI 90d439bb-45a0-42ec-88dd-e8df8d62affb 34 fields · synced May 30, 2026