Biover Microvascular Clamps
EUDAMEDFDA UDIClass IIa (EU MDR)
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 1 to 2 mm FDA UDI
- Model / Reference
- TKM-2 EUDAMEDFDA UDI
- Description
- Disposable Microvascular Clamps, Arteries, double, Ø 1 to 2 mm FDA UDI
Identifiers
- Catalog Number
- TKM-2 FDA UDI
- Primary DI / UDI-DI
- 07640174510061 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Width — 3.0 Millimeter FDA UDILength — 17.0 Millimeter FDA UDI
Category: Surgical bulldog clamp, single-use
Biover Microvascular Clamps by Biover AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical bulldog clamp, single-use.
- KİNG — İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş. · Class III
- Vascular Tourniquet Set, 1 Snare, 5 Tubes — DİSPOSET TIBBİ ÜRÜNLER SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class IIa
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Scanlan® VASCU-STATT® Plus aprox s-use bulldog clamp w/Gentle-Jaw™ surface — SCANLAN INTERNATIONAL INC · Class I
- BM-BID-I30C — BrosMed Medical Co., Ltd. · Class I
- Sterile Vascular Silicone Ties — BATRIK MEDICAL MANUFACTURING INC. · Class IIa
- Scanlan® VASCU-STATT® approximator single-use bulldog clamp — SCANLAN INTERNATIONAL INC · Class I
- BM-BID-I30P — BrosMed Medical Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 b9a51997-e3b4-45e7-9652-e1af3883de84 61 fields · synced May 30, 2026
- FDA UDI ffc58f45-88bb-4b81-9a71-f2fb0a8f2f60 38 fields · synced May 30, 2026