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Inoculation Needles

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 8177CS10HRef 176CSR40Ref 176CS20Ref SN20Ref 612-9366Ref 176CS01Ref 612-2655

by Copan Italia Spa

Identity

Trade Name
Inoculation Needles EUDAMEDFDA UDI
Generic Name
Inoculating tool IVD, manual FDA UDI
Device Name
HARD LOOPS 10 UL STERILE, IN BAGS OF 10 PCS EUDAMED
STERILE NEEDLES IN RESEALABLE BAG OF 40 PIECES EUDAMED
STERILE NEEDLES 20 PIECES PACKED EUDAMED
STERILE NEEDLE 20 PIECES PACKED EUDAMED
INOCULATION NEEDLE STERILE, IN RESEALABLE BAGS OF 40 PCS EUDAMED
STERILE NEEDLE SINGLE PACKED EUDAMED
INOCULATION NEEDLES STERILE, IN BAGS OF 20 PCS EUDAMED
STERILE NEEDLES IN RESEALABLE BAG OF 40 PIECES FDA UDI
Model / Reference
176CSR40 EUDAMEDFDA UDI
8177CS10H EUDAMED
176CS20 EUDAMED
SN20 EUDAMED
612-9366 EUDAMED
176CS01 EUDAMED
612-2655 EUDAMED
Description
STERILE NEEDLES IN RESEALABLE BAG OF 40 PIECES FDA UDI

Identifiers

Catalog Number
176CSR40 FDA UDI
Primary DI / UDI-DI
38053326000554 EUDAMED
38053326001100 EUDAMED
38053326001124 EUDAMED
D-SN20M4 EUDAMED
D-612-93668N EUDAMED
28053326001110 EUDAMED
D-612-26557F EUDAMED
28053326001103 FDA UDI
Basic UDI-DI
B-38053326000554 EUDAMED
B-38053326001100 EUDAMED
B-38053326001124 EUDAMED
B-SN20M4 EUDAMED
B-612-93668N EUDAMED
B-28053326001110 EUDAMED
B-612-26557F EUDAMED
FDA Product Code
LXG FDA UDI
EMDN Code
W05030302 MICROBIOLOGICAL CULTURE, LOOPS EUDAMED
GMDN Term
Inoculating tool IVD, manual FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
862.2050 FDA UDI
Market of Registration
Italy EUDAMED
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Inoculating tool IVD, manual

Inoculation Needles by Copan Italia Spa — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Inoculating tool IVD, manual.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Copan Italia Spa

Sources (8)

  • FDA UDI 89b439bd-4b70-4af5-bda8-b8704b0c454e 34 fields · synced Aug 1, 2026
  • EUDAMED 75ab8cad-0a0c-4984-810b-0073da439800 61 fields · synced Jul 8, 2026
  • EUDAMED 5903af01-86e9-490b-b762-d7547e836b69 61 fields · synced Jul 8, 2026
  • EUDAMED 2ab536b5-21cd-454c-b84c-238ed3b4bbfa 61 fields · synced Jul 9, 2026
  • EUDAMED 1b75c34e-9ee2-4e42-a55a-86f2beb82126 61 fields · synced Jul 10, 2026
  • EUDAMED c71a5f39-55c6-48e1-90cb-eb14767c2415 61 fields · synced Jul 13, 2026
  • EUDAMED 0adf03e1-e74c-46ab-8afb-807d08555160 61 fields · synced Jul 24, 2026
  • EUDAMED f6db70b3-cd35-494d-940f-6fc25fbf363c 61 fields · synced Aug 1, 2026