EU Manufacturer
๐บ๐ธ United States
Active
Spectra Medical Devices, LLC
SRN: US-MF-000008491
ยท
Ballardvale Street 299, 01887 Wilmington, United States
Basic UDI-DIs
4
Total Devices
4
On Market
4
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
5
Basic Information
- Address
- Ballardvale Street 299, 01887 Wilmington, United States
- [email protected]
- Website
- www.spectramedical.com
Regulatory Overview
Regulation
Loading...
Eu Mdd
4
Classification
Loading...
Eu Md Class 2a
3
Eu Md Class 3
1
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 41377776-04 | INTERTEK SEMKO AB | Oct 24, 2023 |
Market Presence
Devices from this manufacturer are available in 5 countries across Europe.
๐ง๐ช Belgium
๐ฌ๐ท Greece
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐น Italy
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Spectra Epidural Needle | EU MDD | Eu Md Class 3 | On Market | 1 |
| Spectra Guide Wire Introducer (GWI) Needle | EU MDD | Eu Md Class 2a | On Market | 1 |
| Spectra Radio Frequency (RF) Needle | EU MDD | Eu Md Class 2a | On Market | 1 |
| Spectra Safe-Cutยฎ Safety Scalpel | EU MDD | Eu Md Class 2a | On Market | 1 |