Identity
- Trade Name
- Streck EUDAMEDSperm-Chex FDA UDI
- Generic Name
- Sperm concentration indicator IVD, control FDA UDI
- Device Name
- Sperm-Chex - 2 x 300 µl L1 & 2 EUDAMEDA sperm count control containing stabilized sperm. Contains 1 vial each of level 1 & 2. FDA UDI
- Model / Reference
- 230202 EUDAMEDFDA UDI
- Description
- A sperm count control containing stabilized sperm. Contains 1 vial each of level 1 & 2. FDA UDI
Identifiers
- Catalog Number
- 230202 FDA UDI
- Primary DI / UDI-DI
- 00844509001867 EUDAMEDFDA UDI
- Basic UDI-DI
- 08445090SPCWT EUDAMED
- Direct Marketing DI
- 00844509001867 EUDAMED
- 510(k) Number
- K041240 FDA UDI
- FDA Product Code
- NRF FDA UDI
- EMDN Code
- W05039099 DEVICES FOR SAMPLES ANALYSES - OTHER EUDAMED
- GMDN Term
- Sperm concentration indicator IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 864.8625 FDA UDI
- Market of Registration
- Germany 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
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 300 Microliter FDA UDI
Streck by Streck — Class B — 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 | 08445090SPCWT | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Streck
- EUDAMED SRN
- US-MF-000013009
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED f39d20c0-f6b7-4eb1-81ef-de1aa071055d 61 fields · synced May 31, 2026
- FDA UDI e7aed697-c8a0-4fb6-9a86-347d7d488cd1 38 fields · synced May 29, 2026