Identity
- Trade Name
- Su-Por® Surgical Implants EUDAMEDSu-Por Surgical Implants FDA UDI
- Generic Name
- Polyethylene craniofacial tissue reconstructive material FDA UDI
- Device Name
- Airo - Large - Qty 2 - 21mm x 9.5mm x 0.45mm FDA UDI
- Model / Reference
- 4445 EUDAMEDFDA UDI
- Description
- Airo - Large - Qty 2 - 21mm x 9.5mm x 0.45mm FDA UDI
Identifiers
- Catalog Number
- 4445 FDA UDI
- Primary DI / UDI-DI
- 00815285022032 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00815285022032 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-00815285022032 | 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 d5bd2022-a93f-4f19-9dec-f7c6784d9d8f 61 fields · synced May 30, 2026
- FDA UDI 7765fef5-b20d-406a-9dd0-f07ca830e88d 35 fields · synced May 29, 2026