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Royaldent
EUDAMEDClass I (EU MDR)
Ref 0852Ref 0865Ref 0853Ref 0861Ref 0864Ref 0854Ref 0860Ref 0851
Identity
- Trade Name
- ROYALDENT EUDAMED
- Device Name
- STERILIZATION REELS AND BAGS EUDAMED
- Model / Reference
- 0852 EUDAMED0865 EUDAMED0853 EUDAMED0861 EUDAMED0864 EUDAMED0854 EUDAMED0860 EUDAMED0851 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476612078 EUDAMED04250476612160 EUDAMED04250476612085 EUDAMED04250476612122 EUDAMED04250476612153 EUDAMED04250476612092 EUDAMED04250476612184 EUDAMED04250476612115 EUDAMED
- Basic UDI-DI
- 42504766STAB EUDAMED
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, PAPER/PLASTIC FILM EUDAMEDS01020101 FLAT STERILISATION REELS, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Royaldent by Akzenta International SA — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504766STAB | Class I | Active |
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Manufacturer
- Manufacturer
- Akzenta International SA
- EUDAMED SRN
- CH-MF-000036434
- Authorised Representative
- IQX GmbH AT-AR-000016713
Sources (8)
- EUDAMED f7b1a84e-b534-4a93-a81b-76d9625e7b40 61 fields · synced Oct 6, 2026
- EUDAMED f9004685-a5b1-4f04-ab93-8b7e42e01482 61 fields · synced May 16, 2026
- EUDAMED 2a632eb9-099f-48fa-859d-3520a5bbab98 61 fields · synced May 16, 2026
- EUDAMED 89ef56d0-4cf2-4112-b4fa-e74b9f818612 61 fields · synced May 17, 2026
- EUDAMED 9dc487ab-7ff2-487d-b79f-d95fdb0d78a0 61 fields · synced May 18, 2026
- EUDAMED 341c0aa7-e530-417e-a3ce-1f1de9d9c094 61 fields · synced May 18, 2026
- EUDAMED a4344353-81fc-4554-b69a-e20f8ab01437 61 fields · synced May 18, 2026
- EUDAMED 935c0d13-720a-4a2c-a3c5-fec965af68dd 61 fields · synced May 18, 2026