Identity
- Device Name
- BIRTH BALL COVER EUDAMED
- Model / Reference
- COMPOFLEX EUDAMEDCOM1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055348430578 EUDAMED
- Basic UDI-DI
- B-08055348430578 EUDAMED
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Birth Ball Cover by Meika Group S.r.l. — 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-08055348430578 | Class I | Active |
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Manufacturer
- Manufacturer
- Meika Group S.r.l.
- EUDAMED SRN
- IT-MF-000029106
Sources (1)
- EUDAMED 12eef62c-f1ea-48db-bbfc-0bcb90d4479d 61 fields · synced Jun 20, 2026