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MT1 Rotary Microtome
EUDAMEDFDA UDIClass A (EU MDR)
Ref 130.022.001-00Model MT1
Identity
- Trade Name
- MT1 Rotary Microtome EUDAMEDFDA UDI
- Generic Name
- Rotary microtome IVD FDA UDI
- Device Name
- Rotary Microtome EUDAMED
- Model / Reference
- MT1 EUDAMEDFDA UDI130.022.001-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971182570978 EUDAMEDFDA UDI
- Basic UDI-DI
- 69711825715VV EUDAMED
- Direct Marketing DI
- 06971182570978 EUDAMED
- FDA Product Code
- IDO FDA UDI
- EMDN Code
- W0202059005 MICROTOMES EUDAMED
- GMDN Term
- Rotary microtome IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Market of Registration
- Italy 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MT1 Rotary Microtome 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 | 69711825715VV | 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 3da18974-9aaa-406e-baf6-ed37cd28d402 61 fields · synced Jul 21, 2026
- FDA UDI 0d64deda-953b-499e-9812-114c626f1b08 32 fields · synced May 30, 2026