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Hair implant system
EUDAMEDClass IIa (EU MDR)
Ref S1BRef SEBRef T3CRef D1CRef D2ARef S1CRef SEARef T3ARef T3BRef S1A
by Incuram
Identity
- Device Name
- Hair implant system EUDAMED
- Model / Reference
- S1B EUDAMEDSEB EUDAMEDT3C EUDAMEDD1C EUDAMEDD2A EUDAMEDS1C EUDAMEDSEA EUDAMEDT3A EUDAMEDT3B EUDAMEDS1A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809640290008 EUDAMED08809640290145 EUDAMED08809640290084 EUDAMED08809640290060 EUDAMED08809640290169 EUDAMED08809640290053 EUDAMED08809640290190 EUDAMED08809640290152 EUDAMED08809640290039 EUDAMED08809640290183 EUDAMED
- Basic UDI-DI
- B-08809640290008 EUDAMEDB-08809640290145 EUDAMEDB-08809640290084 EUDAMEDB-08809640290060 EUDAMEDB-08809640290169 EUDAMEDB-08809640290053 EUDAMEDB-08809640290190 EUDAMEDB-08809640290152 EUDAMEDB-08809640290039 EUDAMEDB-08809640290183 EUDAMED
- EMDN Code
- V901602 DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Hair implant system by Incuram — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08809640290008 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Incuram
- EUDAMED SRN
- KR-MF-000025630
- Authorised Representative
- AeMi World e.K DE-AR-000007704
Sources (10)
- EUDAMED d1e98c04-fc05-48a0-b211-5f4b2f6a3d5c 61 fields · synced Sep 18, 2026
- EUDAMED 37d47198-7df1-44ab-af01-06d67488fc08 61 fields · synced May 17, 2026
- EUDAMED c4553be2-69c7-49a6-81b3-38519b647b65 61 fields · synced May 17, 2026
- EUDAMED 43a5bbde-eef1-4ff9-9d9b-4b64156d6c95 61 fields · synced May 17, 2026
- EUDAMED 3bcfe584-c612-404d-8700-3a9e3fcebc4c 61 fields · synced May 17, 2026
- EUDAMED 3c4b6d1b-e31f-40b7-9073-d865a226d088 61 fields · synced May 18, 2026
- EUDAMED 5b63edd3-1dab-4b9a-9021-9853b13a7cfb 61 fields · synced May 18, 2026
- EUDAMED 459df674-d0ed-443b-a33d-aa759d1127b9 61 fields · synced May 18, 2026
- EUDAMED f22d84ea-b80e-482f-8546-2c7bb55247a3 61 fields · synced May 18, 2026
- EUDAMED 9273a510-0856-4b6e-b3a5-1e4853132c51 61 fields · synced May 18, 2026