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Embedding Cassette
EUDAMEDFDA UDIClass A (EU MDR)
Ref C03Model C-0A-00, C-0B-01, C-0B-00, C-1-00, C-1-02, C-1-01, C00, C01, C02, C03
Identity
- Trade Name
- Embedding Cassette EUDAMEDFDA UDI
- Generic Name
- Histology tissue cassette IVD, laboratory processing, single-use FDA UDI
- Device Name
- Embedding Cassette EUDAMED
- Model / Reference
- C-0A-00, C-0B-01, C-0B-00, C-1-00, C-1-02, C-1-01, C00, C01, C02, C03 EUDAMEDC03 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971182571197 EUDAMEDFDA UDI
- Basic UDI-DI
- 69711825713VR EUDAMED
- FDA Product Code
- KER FDA UDI
- EMDN Code
- W05020106 BIOPSY CARTRIDGES EUDAMED
- GMDN Term
- Histology tissue cassette IVD, laboratory processing, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Embedding Cassette by Dakewe (Shenzhen) Medical Equipment Co., 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 | 69711825713VR | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Dakewe (Shenzhen) Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000009696
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED a93c3d25-b50a-413a-9076-8628d77a8150 61 fields · synced Jul 12, 2026
- FDA UDI 87b4e939-08dc-47a4-b3ad-b039415c5ce1 32 fields · synced May 30, 2026