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Any-Com
EUDAMEDClass IIa (EU MDR)
Ref GB2206RC001Model 301 Any-Com Universal Kit, 302 Any-Com Kit, 301-1 ~ 301-21 Any-Com RefillModel 301-1, 301-2, 301-3, 301-4, 301-5, 301-6, 301-7, 301-8, 301-9, 301-10, 301-11, 301-12, 301-13, 301-14, 301-15, 301-16, 301-17, 301-18, 301-19, 301-20 Any-Com Refill A1, A2, A3, A3.5, A4, B1, B2, B3, C2, C3, D2, D3, WT, OP, OA2, OA3, TL, A2E, A3E, B2E
Identity
- Trade Name
- Any-Com EUDAMED
- Device Name
- Any-Com EUDAMEDDental composite resin EUDAMED
- Model / Reference
- 301 Any-Com Universal Kit, 302 Any-Com Kit, 301-1 ~ 301-21 Any-Com Refill EUDAMEDGB2206RC001 EUDAMED301-1, 301-2, 301-3, 301-4, 301-5, 301-6, 301-7, 301-8, 301-9, 301-10, 301-11, 301-12, 301-13, 301-14, 301-15, 301-16, 301-17, 301-18, 301-19, 301-20 Any-Com Refill A1, A2, A3, A3.5, A4, B1, B2, B3, C2, C3, D2, D3, WT, OP, OA2, OA3, TL, A2E, A3E, B2E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809518345236 EUDAMED08809518340729 EUDAMED
- Basic UDI-DI
- B-08809518345236 EUDAMED880951834RS05NM EUDAMED
- Direct Marketing DI
- 08809518340729 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMEDEUDAMED
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: Dental composite resin
Any-Com by MEDICLUS Co., Ltd. — Class IIa — MDR, 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/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809518345236 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809518345236 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MEDICLUS Co., Ltd.
- EUDAMED SRN
- KR-MF-000022584
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 294fecf6-614d-4403-9ef6-8dd24d1825c5 61 fields · synced Sep 30, 2026
- EUDAMED 3cd22a99-82c2-4057-ae75-1baa6fa6a9f6 61 fields · synced Sep 17, 2026