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Culture Media Tissue
EUDAMEDFDA UDIClass I (EU MDR)
Ref ACS-102Ref ACS-202
by Bsl Co. Ltd.
Identity
- Trade Name
- ACS Combo-B Incubator FDA UDI
- Generic Name
- Aerobic laboratory incubator FDA UDI
- Device Name
- Culture Media Tissue EUDAMED
- Model / Reference
- ACS-102 EUDAMEDFDA UDIACS-202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800080220020 EUDAMEDFDA UDI08800080220044 EUDAMED
- Basic UDI-DI
- 088000802ACS-IVL EUDAMED
- FDA Product Code
- NNL FDA UDI
- EMDN Code
- W02039099 VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Aerobic laboratory incubator FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Culture Media Tissue by BSL Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 088000802ACS-IVL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bsl Co. Ltd.
- EUDAMED SRN
- KR-MF-000025426
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED fbbc9453-f8a8-45e6-83e7-adc7b1a9a13e 61 fields · synced Aug 3, 2026
- EUDAMED 56f80a66-7ef0-4676-9088-cf0b32dc3bcd 61 fields · synced May 18, 2026
- FDA UDI b929fc25-6d50-4a2c-824b-3e2fbc81bbc4 33 fields · synced May 30, 2026