Identity
- Trade Name
- Su-Por Surgical Implants EUDAMEDSU-POR Surgical Implant FDA UDI
- Generic Name
- Polyethylene craniofacial tissue reconstructive material FDA UDI
- Device Name
- Tah-Ear-I Rev. B - Large - Right EUDAMEDTah-Ear-I - Large - Right FDA UDI
- Model / Reference
- 4721 EUDAMEDFDA UDI
- Description
- Tah-Ear-I - Large - Right FDA UDI
Identifiers
- Catalog Number
- 4721 FDA UDI
- Primary DI / UDI-DI
- 00815285025125 EUDAMED00815285024821 FDA UDI
- Basic UDI-DI
- B-00815285025125 EUDAMED
- 510(k) Number
- K140437 FDA UDI
- FDA Product Code
- KKY FDA UDI
- EMDN Code
- P900403 NON-RESORBABLE FILLING AND RECONSTRUCTION DEVICES 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
- Netherlands 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
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
Yes
FDA UDI
MR Safe FDA UDI
Su-Por Surgical Implants by Poriferous, LLC — Class IIb — 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-00815285025125 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Poriferous, LLC
- EUDAMED SRN
- US-MF-000016703
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c6fa6887-f2a7-4c98-b7fd-01c55eeb9070 61 fields · synced Jun 7, 2026
- FDA UDI 5a74d294-5270-4fdb-9b5c-6babac713142 36 fields · synced May 30, 2026