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Augma Shield (Mode: OB23)
EUDAMEDFDA UDIClass I (EU MDR)
Ref TF-AUG-IFUModel OB23
Identity
- Trade Name
- Augma Shield (Mode: OB23) EUDAMEDAugma Shield FDA UDI
- Generic Name
- General oral wound dressing, non-animal-derived FDA UDI
- Device Name
- Ora-Aid EUDAMED
- Model / Reference
- OB23 EUDAMEDFDA UDITF-AUG-IFU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800026800347 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000268AG9R EUDAMED
- 510(k) Number
- K211851 FDA UDI
- FDA Product Code
- MGQ FDA UDIOLR FDA UDI
- EMDN Code
- Q010304 PERIODONTAL DRESSINGS EUDAMED
- GMDN Term
- General oral wound dressing, non-animal-derived FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Augma Shield (Mode: OB23) by TBM Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000268AG9R | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- TBM Corporation
- EUDAMED SRN
- KR-MF-000008542
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED baeb9c41-da31-4374-8e8f-d36f8aac1a84 61 fields · synced Jun 20, 2026
- FDA UDI 5a69f5f4-103c-4bf2-9757-97d6efe7b539 33 fields · synced May 29, 2026