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OmniPore Surgical Implant
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref OP6316Model OP6314
Identity
- Trade Name
- OmniPore Surgical Implant EUDAMEDFDA UDI
- Generic Name
- Polyethylene craniofacial tissue reconstructive material FDA UDI
- Device Name
- OmiPore Surgical Implant EUDAMEDOrbital Sphere FDA UDI
- Model / Reference
- OP6314 EUDAMEDOP6316 EUDAMEDFDA UDI
- Description
- Orbital Sphere FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855421005123 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00855421005123 EUDAMED
- 510(k) Number
- K123908 FDA UDI
- FDA Product Code
- KKY FDA UDI
- EMDN Code
- P0399 OCULAR PROSTHESES - OTHER EUDAMED
- GMDN Term
- Polyethylene craniofacial tissue reconstructive material FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3500 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
OmniPore Surgical Implant by Matrix Surgical Holdings, LLC dba Matrix Surgical USA — Class IIb — 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-00855421005123 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- EUDAMED SRN
- US-MF-000018643
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED fafa2a09-d890-4703-85b8-34f59b11bf79 61 fields · synced Jul 9, 2026
- FDA UDI b047e04e-f792-43ce-aec6-093dd7d37b25 34 fields · synced May 30, 2026