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Doublebase Once
EUDAMEDClass I (EU MDR)
Ref 100158Model Doublebase Once 100gRef 100199Model Doublebase Once OTC 500g
Identity
- Trade Name
- Doublebase Once EUDAMEDDoublebase Once OTC EUDAMED
- Device Name
- Doublebase Once 100g EUDAMEDDoublebase Once OTC 500g EUDAMED
- Model / Reference
- Doublebase Once 100g EUDAMED100158 EUDAMEDDoublebase Once OTC 500g EUDAMED100199 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016379175015 EUDAMED05016379000249 EUDAMED
- Basic UDI-DI
- B-05016379175015 EUDAMEDB-05016379000249 EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Doublebase Once by Diomed Developments Limited — Class I — 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-05016379175015 | Class I | Active |
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Manufacturer
- Manufacturer
- Diomed Developments Limited
- EUDAMED SRN
- GB-MF-000004862
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (2)
- EUDAMED 2648a5a3-8e84-42a7-96df-e016557f3102 61 fields · synced Jul 30, 2026
- EUDAMED e70964dc-394e-4943-88d5-3e70a4bb2f64 61 fields · synced May 18, 2026