← Back to catalogue
Neomem ECM Dental Membrane 30 mm X 40 mm
EUDAMEDFDA UDIClass III (EU MDR)
Ref NX3040Model MD00001
Identity
- Trade Name
- Neomem ECM Dental Membrane 30 mm X 40 mm EUDAMEDNEOMEM® ECM FDA UDI
- Generic Name
- Collagen dental regeneration membrane FDA UDI
- Device Name
- Neomem ECM Dental Membrane EUDAMEDPorcine Extracellular Matrix Dental Membrane FDA UDI
- Model / Reference
- MD00001 EUDAMEDNX3040 EUDAMED30074-03 FDA UDI
- Description
- Porcine Extracellular Matrix Dental Membrane FDA UDI
Identifiers
- Catalog Number
- NX3040 FDA UDI
- Primary DI / UDI-DI
- M263NX30400 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M263NX30400 EUDAMED
- FDA Product Code
- NPL FDA UDI
- EMDN Code
- Q010301 PERIODONTAL MEMBRANES EUDAMED
- GMDN Term
- Collagen dental regeneration membrane FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Market of Registration
- Bulgaria 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 — 40 Millimeter FDA UDIWidth — 30 Millimeter FDA UDI
Neomem ECM Dental Membrane 30 mm X 40 mm 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-M263NX30400 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DSM Biomedical, Inc.
- EUDAMED SRN
- US-MF-000021393
- Authorised Representative
- DSM Biomedical B.V. NL-AR-000018633
Sources (2)
- EUDAMED f119c1b9-f5e6-40d2-b519-b8f8c5875157 61 fields · synced Jun 20, 2026
- FDA UDI 9292e524-9e4f-4fb7-9e8c-8670c3bb7f06 35 fields · synced May 29, 2026