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Haemophilus Test (htm) Supplement
EUDAMEDFDA UDIClass A (EU MDR)
Ref SR0158E
by Oxoid Ltd
Identity
- Trade Name
- HAEMOPHILUS TEST (HTM) SUPPLEMENT EUDAMEDHAEMOPHILUS TEST(HTM)SUPP FDA UDI
- Generic Name
- Culture medium antimicrobial supplement IVD FDA UDI
- Device Name
- HAEMOPHILUS TEST (HTM) SUPPLEMENT EUDAMED
- Model / Reference
- SR0158E EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384012213 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384HaemophTestSup7B EUDAMED
- FDA Product Code
- JSK FDA UDI
- EMDN Code
- W0104010104 ADDITIVES FOR DCM (GROWTH SUPPLEMENTS, SELECTIVE AGENTS, ...) EUDAMED
- GMDN Term
- Culture medium antimicrobial supplement IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2450 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Haemophilus Test (htm) Supplement by Oxoid Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5032384HaemophTestSup7B | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED 18fed958-d055-410d-9d29-5b5271285323 61 fields · synced Jul 29, 2026
- FDA UDI 393071de-9ab1-4a92-a195-fa76d1dd53e5 32 fields · synced May 30, 2026