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Biover Microvascular Clamps
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref TKS-2
by Biover AG
Identity
- Trade Name
- Biover Microvascular Clamps EUDAMEDBiover FDA UDI
- Generic Name
- Vascular clamp, single-use FDA UDI
- Device Name
- Biover Microvascular Clamps EUDAMEDDisposable Microvascular Clamps, Arteries, double, Ø less than 1 mm FDA UDI
- Model / Reference
- TKS-2 EUDAMEDFDA UDI
- Description
- Disposable Microvascular Clamps, Arteries, double, Ø less than 1 mm FDA UDI
Identifiers
- Catalog Number
- TKS-2 FDA UDI
- Primary DI / UDI-DI
- 07640174510023 EUDAMEDFDA UDI
- Basic UDI-DI
- 76401745100BIOVERclampsFQ EUDAMED
- 510(k) Number
- K011208 FDA UDI
- FDA Product Code
- DXC FDA UDI
- EMDN Code
- C0699 CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Vascular clamp, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4450 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 2.5 Millimeter FDA UDILength — 14.5 Millimeter FDA UDI
Biover Microvascular Clamps by Biover AG — Class IIa — 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 | 76401745100BIOVERclampsFQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Biover AG
- EUDAMED SRN
- CH-MF-000036158
- Authorised Representative
- Baxter Deutschland GmbH DE-AR-000010308
Sources (2)
- EUDAMED f7bc2f34-b2ac-447e-9113-4ceb8476ba4f 61 fields · synced Jul 13, 2026
- FDA UDI c035ed45-0bff-4385-b7c7-56eb8e0801ef 38 fields · synced May 30, 2026