EU Manufacturer
๐ฎ๐น Italy
Active
3A HEALTH CARE S.r.l.
SRN: IT-MF-000009298
ยท
Via Marziale Cerutti 90 F/G, 25017 Lonato del Garda, Italy
Basic UDI-DIs
10
Total Devices
61
On Market
54
Off Market
7
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Via Marziale Cerutti 90 F/G, 25017 Lonato del Garda, Italy
- [email protected]
Regulatory Overview
Regulation
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Eu Mdd
5
Eu Mdr
5
Classification
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Eu Md Class 2a
9
Eu Md Class 1
1
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 1947 | IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITร S.P.A. | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| A3 Complete (NE-C300-E) | EU MDD | Eu Md Class 2a | On Market | 1 |
| A3 Complete (NE-C300-ITA) | EU MDD | Eu Md Class 2a | On Market | 1 |
| A3 Complete Accesory Kit (NEB6001) | EU MDD | Eu Md Class 2a | On Market | 1 |
| A3 Complete Accessory Kit (NEB6003) | EU MDD | Eu Md Class 2a | Off Market | 1 |
| Accessory set-1 for C101, C102 (NEB6020) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Accessory set-2 for C101, C102 (NEB6021) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Accessory set-3 for C101, C102 (NEB6022) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Adapter (NEB6015) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Adult Mask (NEB6007) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Adult Mask for C28P (NEB6029) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Air Tube (NEB6004) | EU MDR | Eu Md Class 2a | On Market | 0 |
| C101 Essential (NE-C101-E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| C101 Essential (NE-C101-ITA) | EU MDR | Eu Md Class 2a | On Market | 0 |
| C102 Total (NE-C102-D) | EU MDR | Eu Md Class 2a | On Market | 0 |
| C102 Total (NE-C102-E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| C102 Total (NE-C102-ITA) | EU MDR | Eu Md Class 2a | On Market | 0 |
| C102 Total (NE-C102-KSA) | EU MDR | Eu Md Class 2a | Not EU | 0 |
| C102 Total (NE-C102-UK) | EU MDR | Eu Md Class 2a | On Market | 0 |
| C28P (NE-C105-D) | EU MDR | Eu Md Class 2a | On Market | 0 |
| C28P (NE-C105-E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| C28P (NE-C105-KSA) | EU MDR | Eu Md Class 2a | Not EU | 0 |
| C28P (NE-C105-UK) | EU MDR | Eu Md Class 2a | On Market | 0 |
| C28P Accessory Set Adult (NEB6034) | EU MDR | Eu Md Class 2a | On Market | 0 |
| C28P Accessory Set Child (NEB6035) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Child Mask for C28 (NEB6008) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Child Mask for C28 (NEB6028) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Compact (NE-C101-D) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Disposable Suction Liner 1 Lt (3AC461) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Disposable Suction Liner 1 Lt (3AC477) | EU MDR | Eu Md Class 1 | On Market | 0 |
| DuoBaby (NE-C301-D) | EU MDR | Eu Md Class 2a | On Market | 0 |
| DuoBaby (NE-C301-E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| DuoBaby (NE-C301-ITA) | EU MDR | Eu Md Class 2a | On Market | 0 |
| DuoBaby (NE-C301-KSA) | EU MDR | Eu Md Class 2a | Not EU | 0 |
| DuoBaby (NE-C301-UK) | EU MDR | Eu Md Class 2a | Not EU | 0 |
| DuoBaby Aspirator Accessory set (NEB7000) | EU MDR | Eu Md Class 2a | On Market | 0 |
| DuoBaby Nebulizer Accessory set (NEB2012) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Mouthpiece (NEB6005) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Mouthpiece Set for C28P (NEB6027) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Mouthpiece for C101, C102, Nami Cat, Neko Kat (NEB6019) | EU MDR | Eu Md Class 2a | On Market | 0 |
| NE-C300 Nebulizer Kit (NEB6002) | EU MDD | Eu Md Class 2a | Off Market | 1 |
| NE-C301 Air Tube (NEB6016) | EU MDR | Eu Md Class 2a | On Market | 0 |
| NE-C301 Nebulizer kit (NEB6010) | EU MDR | Eu Md Class 2a | On Market | 0 |
| NE-C301 Nebulizer kit (NEB6011) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Nami Cat (NE-C303-KDD) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Nami Cat (NE-C303K-KDE) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Nami Cat (NE-C303K-KDEO) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Nami Cat (NE-C303K-KDITA) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Nami Cat (NE-C303K-KDKSA) | EU MDR | Eu Md Class 2a | Not EU | 0 |
| Nami Cat (NE-C303K-KDUK) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Nasal Shower (NEB-NSSW-11AP) | EU MDR | Eu Md Class 2a | On Market | 0 |