Identity
- Trade Name
- Non-resorbable membrane EUDAMEDInnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-Mesh FDA UDI
- Generic Name
- Pliable-polymer dental regeneration membrane, non-bioabsorbable FDA UDI
- Device Name
- InnoGenicTM PTFE-Mesh EUDAMED
- Model / Reference
- TS24301 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809471726400 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809471726400 EUDAMED
- 510(k) Number
- K211554 FDA UDI
- FDA Product Code
- NPK FDA UDI
- EMDN Code
- Q010301 PERIODONTAL MEMBRANES EUDAMED
- GMDN Term
- Pliable-polymer dental regeneration membrane, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3930 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
Non-resorbable membrane by Cowellmedi Co., Ltd — Class IIa — 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-08809471726400 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Cowellmedi Co., Ltd.
- EUDAMED SRN
- KR-MF-000009689
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 6d1a01be-3a1f-479b-bd0c-7a10ea32aa42 61 fields · synced May 30, 2026
- FDA UDI d9286a40-c24a-45e1-b03d-d0b2aee60495 33 fields · synced May 24, 2026