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iSR'obot Biopsy Kit

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref G4AA610

by Biobot Surgical Pte Ltd

Identity

Trade Name
iSR'obot Biopsy Kit FDA UDI
Generic Name
Needle guide, single-use FDA UDI
Device Name
iSR'obot Biopsy Kit EUDAMED
Model / Reference
G4AA610 EUDAMED
iSR'obot Biopsy Kit FDA UDI

Identifiers

Catalog Number
G4AA610 FDA UDI
Primary DI / UDI-DI
08885014610023 EUDAMEDFDA UDI
Basic UDI-DI
B-08885014610023 EUDAMED
510(k) Number
K163502 FDA UDI
K232320 FDA UDI
FDA Product Code
OIJ FDA UDI
EMDN Code
Z12169085 VARIOUS INSTRUMENTS FOR UROLOGY - CONSUMABLES EUDAMED
GMDN Term
Needle guide, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
Market of Registration
Germany 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

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

iSR'obot Biopsy Kit by Biobot Surgical Pte. Ltd. — Class IIa — FDA_510K, MDD — 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/MDD

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Manufacturer

Manufacturer
Biobot Surgical Pte Ltd
EUDAMED SRN
SG-MF-000020631
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED 4f6e96bf-5cbe-4954-a7e9-aa937cebadd7 61 fields · synced Jul 21, 2026
  • FDA UDI f6cfd6bd-8b66-483a-acfe-074a86d56c83 34 fields · synced May 27, 2026
  • FDA 510(k) K163502 1 fields · synced May 18, 2026