EU Manufacturer
๐ฉ๐ช Germany
Active
R-Biopharm AG
SRN: DE-MF-000007993
ยท
An der neuen Bergstraรe 17, 64297 Darmstadt, Germany
Basic UDI-DIs
82
Total Devices
220
On Market
215
Off Market
5
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- An der neuen Bergstraรe 17, 64297 Darmstadt, Germany
- [email protected]
- Website
- www.r-biopharm.de
Regulatory Overview
Regulation
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Eu Ivdr
82
Classification
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Eu Ivd Class B
40
Eu Ivd Class A
28
Eu Ivd Class C
14
Device Types
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Certificate Health
No certificates registered for this manufacturer.
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 | ||||
|---|---|---|---|---|
| A1-ANTITRYPSIN (PROTEASE INHIBITOR) | EU IVDR | Eu Ivd Class B | On Market | 0 |
| A1-ANTITRYPSIN (PROTEASE INHIBITOR) | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ADALIMUMAB | EU IVDR | Eu Ivd Class C | On Market | 0 |
| ADALIMUMAB | EU IVDR | Eu Ivd Class C | On Market | 0 |
| ADENOVIRUS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ADENOVIRUS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ADENOVIRUS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ADENOVIRUS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ADENOVIRUS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ALLERGENE SPECIFIC IGG | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ALLERGENE SPECIFIC IGG | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ALLERGENE SPECIFIC IGG | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ASTROVIRUS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ASTROVIRUS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ASTROVIRUS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ASTROVIRUS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| ASTROVIRUS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) | EU IVDR | Eu Ivd Class A | Not EU | 0 |
| AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) | EU IVDR | Eu Ivd Class A | Not EU | 0 |
| AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BACTERIOLOGY IMMUNOASSAY - OTHER | EU IVDR | Eu Ivd Class B | On Market | 0 |
| BACTERIOLOGY IMMUNOASSAY - OTHER | EU IVDR | Eu Ivd Class B | On Market | 0 |
| BACTERIOLOGY IMMUNOASSAY - OTHER | EU IVDR | Eu Ivd Class B | On Market | 0 |
| BACTERIOLOGY IMMUNOASSAY - OTHER | EU IVDR | Eu Ivd Class B | On Market | 0 |
| BACTERIOLOGY IMMUNOASSAY - OTHER | EU IVDR | Eu Ivd Class B | On Market | 0 |
| BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC | EU IVDR | Eu Ivd Class A | On Market | 0 |
| C.DIFFICILE BY NA REAGENTS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE BY NA REAGENTS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE BY NA REAGENTS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE BY NA REAGENTS | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE GDH DETECTION | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE GDH DETECTION | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE GDH DETECTION | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE GDH DETECTION | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE GDH DETECTION | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE GDH DETECTION | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE GDH DETECTION | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE TOXIN A/B DETECTION | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE TOXIN A/B DETECTION | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE TOXIN A/B DETECTION | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE TOXIN A/B DETECTION | EU IVDR | Eu Ivd Class B | On Market | 0 |
| C.DIFFICILE TOXIN A/B DETECTION | EU IVDR | Eu Ivd Class B | On Market | 0 |