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Inoculation Loops

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 8175CS20HRef 612-9354Ref 612-9353Ref 177CS01Ref 612-9352Ref 612-9355Ref 8175CS10HRef 612-9351Ref 612-9361Ref 612-9357Ref 612-9359Ref 178CSR40Ref 612-9362Ref 8177CSR40HRef 178CS40Ref 178CS20

by Copan Italia Spa

Identity

Trade Name
Inoculation Loops EUDAMEDFDA UDI
Generic Name
Inoculating tool IVD, manual FDA UDI
Device Name
SOFT LOOPS 1 UL STERILE, IN BAG OF 20 PCS EUDAMEDFDA UDI
HARD LOOP 1 µL STERILE, IN BAGS OF 20 PCS EUDAMED
HARD LOOP 10 UL STERILE, IN BAGS OF 20 PCS EUDAMED
HARD LOOP 10 UL STERILE, IN BAGS OF 10 PCS EUDAMED
HARD LOOPS 10 UL STERILE, SINGLE WRAPPED EUDAMED
Hard loop 1 ul sterile, in bags of 20 pcs EUDAMED
SOFT LOOP 1 ul STERILE, IN BAGS OF 10 PCS EUDAMED
HARD LOOP 1 UL STERILE, IN BAGS OF 10 PCS EUDAMED
SOFT LOOP 1 ul STERILE, IN RESEALABLE BAGS OF 40 PCS EUDAMED
SOFT LOOP 10 UL STERILE, IN BAGS OF 10 PCS EUDAMED
HARD LOOP 10 UL STERILE, IN RESEALABLE BAGS OF 40 PCS EUDAMED
SOFT LOOPS 1 µl STERILE IN RESEABLE BAG 40 PCS PACKED EUDAMED
SOFT LOOP 10 ul STERILE, IN RESEALABLE BAGS OF 40 PCS EUDAMED
HARD LOOP 10 µL STERILE, IN RESEALABLE BAGS OF 40 PCS EUDAMED
SOFT LOOPS 1 UL STERILE, IN BAG OF 40 PCS EUDAMED
Model / Reference
178CS20 EUDAMEDFDA UDI
8175CS20H EUDAMED
612-9354 EUDAMED
612-9353 EUDAMED
177CS01 EUDAMED
612-9352 EUDAMED
612-9355 EUDAMED
8175CS10H EUDAMED
612-9351 EUDAMED
612-9361 EUDAMED
612-9357 EUDAMED
612-9359 EUDAMED
178CSR40 EUDAMED
612-9362 EUDAMED
8177CSR40H EUDAMED
178CS40 EUDAMED
Description
SOFT LOOPS 1 UL STERILE, IN BAG OF 20 PCS FDA UDI

Identifiers

Catalog Number
178CS20 FDA UDI
Primary DI / UDI-DI
38053326000721 EUDAMED
D-612-93548F EUDAMED
D-612-93538D EUDAMED
D-177CS018S EUDAMED
D-612-93528B EUDAMED
D-612-93558H EUDAMED
38053326000547 EUDAMED
58053326010540 EUDAMED
D-612-93618C EUDAMED
D-612-93578M EUDAMED
D-612-93598R EUDAMED
38053326001155 EUDAMED
D-612-93628E EUDAMED
38053326004323 EUDAMED
D-178CS409F EUDAMED
38053326001179 EUDAMED
28053326001172 FDA UDI
Basic UDI-DI
B-38053326000721 EUDAMED
B-612-93548F EUDAMED
B-612-93538D EUDAMED
B-177CS018S EUDAMED
B-612-93528B EUDAMED
B-612-93558H EUDAMED
B-38053326000547 EUDAMED
B-58053326010540 EUDAMED
B-612-93618C EUDAMED
B-612-93578M EUDAMED
B-612-93598R EUDAMED
B-38053326001155 EUDAMED
B-612-93628E EUDAMED
B-38053326004323 EUDAMED
B-178CS409F EUDAMED
B-38053326001179 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 Loops 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Copan Italia Spa

Sources (17)

  • FDA UDI 359ab090-e342-4e3d-ad70-7f8839f2aa70 34 fields · synced Sep 18, 2026
  • EUDAMED cc56518c-ee27-43f3-880e-87c90205127f 61 fields · synced Jun 20, 2026
  • EUDAMED d429ec71-622a-4873-8f66-701d207456d8 61 fields · synced Jul 8, 2026
  • EUDAMED 6f5c9f4d-23a3-4e0d-b715-16e9cbd2c128 61 fields · synced Jul 9, 2026
  • EUDAMED ba861eae-f2c9-42c1-bed5-43005bb2927e 61 fields · synced Jul 9, 2026
  • EUDAMED 23684e02-3341-480b-87f6-ef132eb9966d 61 fields · synced Jul 9, 2026
  • EUDAMED d80488c7-5601-4cc4-a60b-509739c38d10 61 fields · synced Jul 10, 2026
  • EUDAMED afb41a78-ae58-4ad0-8e09-b10c991e84bb 61 fields · synced Jul 12, 2026
  • EUDAMED 49c441f4-1ae4-43e8-8183-80962a9f6f15 61 fields · synced Jul 14, 2026
  • EUDAMED dcbc6949-8ebd-40c2-be12-4ac397b02086 61 fields · synced Jul 14, 2026
  • EUDAMED e0510b12-f705-408d-bb84-5069a1d85984 61 fields · synced Jul 15, 2026
  • EUDAMED b9e9faa3-d3bb-4099-bda9-0aeaa2f48cb9 61 fields · synced Jul 17, 2026
  • EUDAMED 549a5adb-0b63-435f-9e63-abd59bd5ebc2 61 fields · synced Jul 18, 2026
  • EUDAMED 6b5fa682-0364-46f0-8269-c9dd00b56964 61 fields · synced Jul 20, 2026
  • EUDAMED 71c95be4-1b96-4f50-a32a-218029652b47 61 fields · synced Jul 22, 2026
  • EUDAMED ead0523d-28d5-4e81-b5fd-89bfbd5679bf 61 fields · synced Jul 23, 2026
  • EUDAMED a4228bf9-a711-4fdb-bff6-2c2740a4da3a 61 fields · synced Sep 18, 2026