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Tse-Siz-Ns
EUDAMEDClass IIb (EU MDR)
Ref TSE-SIZ-NSModel Silicone Facial Implant
Identity
- Model / Reference
- Silicone Facial Implant EUDAMEDTSE-SIZ-NS EUDAMED
Identifiers
- Primary DI / UDI-DI
- M724TSESIZNS1 EUDAMED
- Basic UDI-DI
- B-M724TSESIZNS1 EUDAMED
- EMDN Code
- P010102 ZYGOMATIC PROSTHESES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Malar prosthesis
Tse-Siz-Ns by Implantech Associates, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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- Dental Gracey Currettes — Burhan Kamran Industries · Class I
- Malar Implant — Hanson Medical, Inc. · Class II
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-M724TSESIZNS1 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Implantech Associates, Inc.
- EUDAMED SRN
- US-MF-000008458
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED fc8b39b1-6da8-451e-b1de-4c46014cc72d 61 fields · synced Jul 27, 2026