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Biover Microvascular Clamps

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref TKFV-1510(k) K011208

by Biover AG

Identity

Trade Name
Biover Microvascular Clamps EUDAMED
Biover FDA UDI
Generic Name
Vascular clamp, single-use FDA UDI
Device Name
Biover Microvascular Clamps EUDAMED
Disposable Microvascular Clamps, Veins, single, Ø 0.2 to 1 mm FDA UDI
Model / Reference
TKFV-1 EUDAMEDFDA UDI
Description
Disposable Microvascular Clamps, Veins, single, Ø 0.2 to 1 mm FDA UDI

Identifiers

Catalog Number
TKFV-1 FDA UDI
Primary DI / UDI-DI
07640174510122 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 EUDAMED
Class 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 — 2.3 Millimeter FDA UDI
Length — 11.0 Millimeter FDA UDI

Biover Microvascular Clamps by Biover AG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Biover AG
EUDAMED SRN
CH-MF-000036158
Authorised Representative
Baxter Deutschland GmbH DE-AR-000010308

Sources (3)

  • EUDAMED f6d7f69f-0ead-4698-82c1-92a05b13e99a 85 fields · synced Jun 18, 2026
  • FDA UDI 027b6342-f239-4e2a-ab72-30b4af032190 38 fields · synced May 30, 2026
  • FDA 510(k) K011208 1 fields · synced May 18, 2026