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Gambaletto 12 Nero 4^ P. Aperta
EUDAMEDClass I (EU MDR)
Ref 8053685721397Ref 8053685721304
Identity
- Trade Name
- GAMBALETTO 12 NERO 4^ P. APERTA EUDAMEDGAMBALETTO 12 NERO 4^ EUDAMED
- Device Name
- GAMBALETTO 12 P. APERTA EUDAMEDGAMBALETTO 12 NATURALE EUDAMED
- Model / Reference
- 8053685721397 EUDAMED8053685721304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053685721397 EUDAMED08053685721304 EUDAMED
- Basic UDI-DI
- 80536857213350107JU EUDAMED80536857211510106H6 EUDAMED
- EMDN Code
- M030405 COMPRESSION STOCKINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Category: Compression/pressure sock/stocking, single-use
Gambaletto 12 Nero 4^ P. Aperta by New Medical Service Srl — Class I — MDR — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 80536857213350107JU | Class I | Active |
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Manufacturer
- Manufacturer
- New Medical Service Srl
- EUDAMED SRN
- IT-MF-000034543
Sources (2)
- EUDAMED 47bb731e-b89f-4ff8-aef3-55ac0b384a2f 61 fields · synced Oct 6, 2026
- EUDAMED 8b2e1896-cd1a-4240-b6d4-b238960b6d59 61 fields · synced May 19, 2026