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Royal Progress, S.l.
EUDAMEDClass IIa (EU MDR)
Ref DC035308Model 0.5mL 30Gx5/16"
Identity
- Trade Name
- ROYAL PROGRESS, S.L. EUDAMED
- Device Name
- Safelock Disposable Insulin Syringes EUDAMED
- Model / Reference
- 0.5mL 30Gx5/16" EUDAMEDDC035308 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971564469562 EUDAMED
- Basic UDI-DI
- B-06971564469562 EUDAMED
- EMDN Code
- A0201060301 INSULIN SYRINGES WITH SAFETY SYSTEMS AND FIXED NEEDLES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Royal Progress, S.l. by Jiangsu Caina Medical Co., Ltd. — 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-06971564469562 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2ccbb62a-6fb6-4dd0-9e5c-6d2e6d6ee64f 61 fields · synced Jun 18, 2026