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XCM Biologic™ Tissue Matrix, Hydrated 4cm x 16cm
EUDAMEDFDA UDIClass III (EU MDR)
Ref XM106.0416SModel EM00040
Identity
- Trade Name
- XCM Biologic™ Tissue Matrix, Hydrated 4cm x 16cm EUDAMEDXCM Biologic® Tissue Matrix FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- XCM Biologic™ Tissue Matrix, Hydrated EUDAMED
- Model / Reference
- EM00040 EUDAMEDXM106.0416S EUDAMED30010-08 FDA UDI
Identifiers
- Catalog Number
- XM106.0416S FDA UDI
- Primary DI / UDI-DI
- 00812337022088 EUDAMED00812337020084 FDA UDI
- Basic UDI-DI
- B-00812337022088 EUDAMED
- FDA Product Code
- OXH FDA UDIOXE FDA UDIOXB FDA UDIFTM FDA UDI
- EMDN Code
- P900299 SURGICAL MESHES - OTHER EUDAMED
- GMDN Term
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Market of Registration
- Austria 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
- Length — 16 Centimeter FDA UDIWidth — 4 Centimeter FDA UDI
XCM Biologic™ Tissue Matrix, Hydrated 4cm x 16cm by Dsm Biomedical, Inc. — Class III — 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-00812337022088 | 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 bff0b6a3-f978-4199-a3e9-119351444767 61 fields · synced Jun 18, 2026
- FDA UDI a5fe5faa-eb77-4601-b392-6e679b065ad7 34 fields · synced May 30, 2026