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Aptē
EUDAMEDClass IIb (EU MDR)
Ref SKA30050Model APSRef SKA1001000Ref SKA10020Ref SKA10025Ref SKA10005Ref SKA30070Ref SKA6040Ref SKA3003000Ref SKA30020Ref SKA6050Ref SKA6020Ref SKA30080
Identity
- Trade Name
- APTĒ EUDAMED
- Device Name
- APTĒ EUDAMED
- Model / Reference
- APS EUDAMEDSKA30050 EUDAMEDSKA1001000 EUDAMEDSKA10020 EUDAMEDSKA10025 EUDAMEDSKA10005 EUDAMEDSKA30070 EUDAMEDSKA6040 EUDAMEDSKA3003000 EUDAMEDSKA30020 EUDAMEDSKA6050 EUDAMEDSKA6020 EUDAMEDSKA30080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052204714254 EUDAMED08052204714186 EUDAMED08052204714124 EUDAMED08052204714179 EUDAMED08052204714131 EUDAMED08052204714100 EUDAMED08052204714261 EUDAMED08052204714070 EUDAMED08052204714292 EUDAMED08052204714223 EUDAMED08052204714087 EUDAMED08052204714063 EUDAMED08052204714278 EUDAMED
- Basic UDI-DI
- 80522047103SKAQR EUDAMED
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Elastomeric infusion pump system
Aptē by Adria Med S.r.l. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Elastomeric infusion pump system.
- SMARTeZ Plus-PainBloc-Fixed Flow 240-10-24h — Epic International (Thailand) Co., Ltd. · Class IIa
- Elastomeric Infusion Pump — Poly Medicure Limited · Class IIb
- SMARTeZ RS-General Infusion 250-500-30m with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
- Neofuser Twin — S&S Med Co.,Ltd. · Class IIb
- Halyard — Avanos Medical, Inc. · Class II
- SMARTeZ RS-PainBloc-Fixed Flow Rate 120-5-24h with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
- SMARTeZ Pump 500-40-12.5h — Epic International (Thailand) Co., Ltd. · Class IIa
- Halyard — Avanos Medical, Inc. · Class II
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 | 80522047103SKAQR | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Adria Med S.r.l.
- EUDAMED SRN
- IT-MF-000020866
Sources (13)
- EUDAMED 2c02b7ff-b5ab-431a-9137-a3fb41c3d74b 61 fields · synced Aug 2, 2026
- EUDAMED 1d003a8b-e306-40f8-a5af-0336899e6abf 61 fields · synced May 17, 2026
- EUDAMED 77feccaa-6c2d-4b3c-a2fa-6710a6da5d44 61 fields · synced May 17, 2026
- EUDAMED b4873929-c650-4074-97ce-d54c17d906c0 61 fields · synced May 17, 2026
- EUDAMED a3878fa9-efa7-4822-bb2e-e6667eca564c 61 fields · synced May 17, 2026
- EUDAMED aeb47a63-21a8-447b-8e54-a95de513e0fd 61 fields · synced May 17, 2026
- EUDAMED 75eed8d1-f5b6-458b-9d7d-fdd7b9c44221 61 fields · synced May 18, 2026
- EUDAMED aa498e68-c695-46c5-96b9-360c7cf22cea 61 fields · synced May 18, 2026
- EUDAMED e786eeb5-332c-4e69-9285-08644e6b67c8 61 fields · synced May 18, 2026
- EUDAMED 3d72d930-667b-4f48-83e3-a1186393406a 61 fields · synced May 18, 2026
- EUDAMED ece481a9-c5ee-40fc-afbc-eb88e3a29fa0 61 fields · synced May 18, 2026
- EUDAMED 1e6e1a0e-9706-477e-9c83-4c663340e927 61 fields · synced May 18, 2026
- EUDAMED 6f8342c4-7d82-4ba8-a1f3-a169aa80ae47 61 fields · synced May 19, 2026