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TnR Mesh
EUDAMEDClass III (EU MDR)
Ref BS08-2540, BS05-1040, AS05-1040, CS05-1040, BS10-1040, BS08-1040, CS08-1030, AS08-1040, AS10-1030
Identity
- Device Name
- TnR Mesh EUDAMED
- Model / Reference
- BS08-2540, BS05-1040, AS05-1040, CS05-1040, BS10-1040, BS08-1040, CS08-1030, AS08-1040, AS10-1030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800061013726 EUDAMED
- Basic UDI-DI
- B-08800061013726 EUDAMED
- EMDN Code
- P010199 FACIAL PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Silicone-block tissue reconstructive material
TnR Mesh by T&R Biofab Co., Ltd — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800061013726 | Class III | Active |
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Manufacturer
- Manufacturer
- T&R Biofab Co., Ltd.
- EUDAMED SRN
- KR-MF-000026617
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 6c7f9caf-8646-4cde-a1d2-3769b3eac567 61 fields · synced Jun 19, 2026
- EUDAMED 6c7f9caf-8646-4cde-a1d2-3769b3eac567-1 61 fields · synced Jun 10, 2026