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Ultracol
EUDAMEDClass III (EU MDR)
Ref U00110Model ULTRACOL100Ref U00050Model ULTRACOL50Ref U00210Model ULTRACOL200
Identity
- Trade Name
- ULTRACOL EUDAMED
- Model / Reference
- ULTRACOL100 EUDAMEDU00110 EUDAMEDULTRACOL50 EUDAMEDU00050 EUDAMEDULTRACOL200 EUDAMEDU00210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070100059 EUDAMED08800070100134 EUDAMED08800022600057 EUDAMED
- Basic UDI-DI
- B-08800070100059 EUDAMEDB-08800070100134 EUDAMEDB-08800022600057 EUDAMED
- EMDN Code
- P010199 FACIAL PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland 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
Ultracol by ULTRA V 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-08800070100059 | Class III | Active |
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Manufacturer
- Manufacturer
- ULTRA V Co., Ltd.
- EUDAMED SRN
- KR-MF-000022614
- Authorised Representative
- Intermundien - Lemon Europe GmbH DE-AR-000011931
Sources (3)
- EUDAMED 9420e895-4e53-4115-ac87-cf15018c1afb 61 fields · synced Jul 14, 2026
- EUDAMED 935c99dd-31b4-408d-9df8-b3ae236b1b38 61 fields · synced May 18, 2026
- EUDAMED 6415fe7f-7be6-4ddb-8edc-be5a5faa1409 61 fields · synced May 18, 2026