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droplet

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 8118Model Type 810Ref 4049Ref 4006Ref 4078Ref 4038Ref 8011Ref 4033Ref 4022Ref 4031Ref 4115Ref 7492Model type 810Ref 7487Model Type 560Ref 4004Ref 4030Ref 9541Ref 4152Ref 4024Ref 4039Ref 4026Ref 4027Ref 4036Ref 7491Ref 4155Ref 4009Ref 4007Ref 4072Ref 8014Ref 4025Ref 4142Ref 8012Ref 7484Ref 7893Ref 4157Ref 4144Ref 8040Ref 8045Ref 8053Ref 8051Ref 7891Ref 7494Ref 8006Model type 810 Ref 8037Ref 8010Ref 9542Model Type 710Ref 8019Ref 7485Ref 7486Ref 8119Ref 7306Ref 4141Ref 8038Ref 8052Ref 8039Ref 4029

by HTL-Strefa S.A.

Identity

Trade Name
droplet EUDAMED
droplet® pen needles FDA UDI
Generic Name
Autoinjector needle FDA UDI
Device Name
Pen needle EUDAMED
droplet EUDAMED
Personal lancet EUDAMED
Lancing device EUDAMED
4 pcs sterile, single use droplet® pen needles per bag, intended to be used with a pen injector device for the subcutaneous injection of insulin drugs. FDA UDI
Model / Reference
Type 810 EUDAMED
8118 EUDAMED
4049 EUDAMED
4006 EUDAMED
4078 EUDAMED
4038 EUDAMED
8011 EUDAMED
4033 EUDAMED
4022 EUDAMED
4031 EUDAMED
4115 EUDAMED
7492 EUDAMED
Type 560 EUDAMED
7487 EUDAMED
4004 EUDAMED
4030 EUDAMED
9541 EUDAMED
4152 EUDAMED
4024 EUDAMED
4039 EUDAMED
4026 EUDAMED
4027 EUDAMED
4036 EUDAMED
7491 EUDAMED
4155 EUDAMED
4009 EUDAMED
4007 EUDAMED
4072 EUDAMED
8014 EUDAMED
4025 EUDAMED
4142 EUDAMED
8012 EUDAMED
7484 EUDAMED
7893 EUDAMED
4157 EUDAMED
4144 EUDAMED
8040 EUDAMED
8045 EUDAMED
8053 EUDAMED
8051 EUDAMED
7891 EUDAMED
7494 EUDAMED
8006 EUDAMED
8037 EUDAMED
8010 EUDAMED
Type 710 EUDAMED
9542 EUDAMED
8019 EUDAMED
7485 EUDAMED
7486 EUDAMED
8119 EUDAMED
7306 EUDAMED
4141 EUDAMED
8038 EUDAMED
8052 EUDAMED
8039 EUDAMED
4029 EUDAMED
31G x 8 mm FDA UDI
Description
4 pcs sterile, single use droplet® pen needles per bag, intended to be used with a pen injector device for the subcutaneous injection of insulin drugs. FDA UDI

Identifiers

Catalog Number
8006 FDA UDI
Primary DI / UDI-DI
05907996093489 EUDAMED
05903999609610 EUDAMED
05903999606060 EUDAMED
05903999608095 EUDAMED
05903999607319 EUDAMED
05907996093441 EUDAMED
05903999607265 EUDAMED
05903999607159 EUDAMED
05903999607241 EUDAMED
05903999608125 EUDAMED
05907996098217 EUDAMED
05907996098897 EUDAMED
05903999606046 EUDAMED
05903999607234 EUDAMED
05903999608262 EUDAMED
05903999608170 EUDAMED
05903999607173 EUDAMED
05903999607326 EUDAMED
05903999607197 EUDAMED
05903999607203 EUDAMED
05903999607296 EUDAMED
05907996098200 EUDAMED
05903999609771 EUDAMED
05903999606091 EUDAMED
05903999606077 EUDAMED
05903999607609 EUDAMED
05907996093519 EUDAMED
05903999607180 EUDAMED
05903999609139 EUDAMED
05907996093458 EUDAMED
05907996098866 EUDAMED
05907996098545 EUDAMED
05903999609795 EUDAMED
05903999609153 EUDAMED
05907996095452 EUDAMEDFDA UDI
05907996098279 EUDAMED
D-8045BD EUDAMED
05907996093649 EUDAMED
05907996093625 EUDAMED
05907996098514 EUDAMED
05907996098231 EUDAMED
05907996098248 EUDAMED
05907996093434 EUDAMED
05903999608279 EUDAMED
05907506237846 EUDAMED
05907996098873 EUDAMED
05907996098880 EUDAMED
05907996093472 EUDAMED
05907996092963 EUDAMED
05903999609122 EUDAMED
05907996098255 EUDAMED
05907996093632 EUDAMED
05907996098262 EUDAMED
05903999607227 EUDAMED
Basic UDI-DI
590799609810MR EUDAMED
590799609810EFH EUDAMED
B-05907996098217 EUDAMED
B-05907996098897 EUDAMED
590799609560MR EUDAMED
B-05907996098200 EUDAMED
B-05907996098866 EUDAMED
B-05907996098545 EUDAMED
B-05907996098279 EUDAMED
B-8045BD EUDAMED
B-05907996093649 EUDAMED
B-05907996093625 EUDAMED
B-05907996098514 EUDAMED
B-05907996098231 EUDAMED
B-05907996095452 EUDAMED
B-05907996098248 EUDAMED
590799609710ML EUDAMED
B-05907506237846 EUDAMED
B-05907996098873 EUDAMED
B-05907996098880 EUDAMED
B-05907996092963 EUDAMED
B-05907996098255 EUDAMED
B-05907996093632 EUDAMED
B-05907996098262 EUDAMED
Direct Marketing DI
05903999608279 EUDAMED
FDA Product Code
FMI FDA UDI
EMDN Code
A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
GMDN Term
Autoinjector needle FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I EUDAMED
Class II FDA UDI
Regulation Number
880.5570 FDA UDI
Market of Registration
France EUDAMED
Spain EUDAMED
Poland EUDAMED
Germany EUDAMED
Netherlands EUDAMED
Finland EUDAMED
Hungary EUDAMED
Latvia EUDAMED
Belgium EUDAMED
Lithuania EUDAMED
Italy EUDAMED
Greece EUDAMED
Czechia EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIEUDAMED

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

Yes

EUDAMEDEUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

Yes

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

No

FDA UDI

droplet by Htl Strefa S A — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
HTL-Strefa S.A.
EUDAMED SRN
PL-MF-000002198

Sources (55)

  • EUDAMED 06fb03aa-2311-4b1d-a89d-d86b0f8e9b94 61 fields · synced Sep 30, 2026
  • EUDAMED 917dea0e-b3f7-4b76-a417-6b114b347dfc 61 fields · synced May 16, 2026
  • EUDAMED fef30f7d-2601-4c8a-aec7-0bcf5cc0383e 61 fields · synced May 16, 2026
  • EUDAMED 15cecb22-2fc2-4f2a-8073-8d92120ce880 61 fields · synced May 16, 2026
  • EUDAMED 07ac3174-06b0-4405-8e93-d9719f0ce802 61 fields · synced May 16, 2026
  • EUDAMED 382d90d8-f65a-45a7-a64d-c762556812a0 61 fields · synced May 16, 2026
  • EUDAMED f513b2a3-93a6-4e47-a38c-90b4131fe379 61 fields · synced May 16, 2026
  • EUDAMED fde5cb63-84f8-4f72-82b7-16c29c68bbfd 61 fields · synced May 17, 2026
  • EUDAMED 2bebf5ae-4732-4738-ae92-155ca59bc8fb 61 fields · synced May 17, 2026
  • EUDAMED 78c5dd6e-290f-47fe-a5e9-a8f26a1a8214 61 fields · synced May 17, 2026
  • EUDAMED a1c7106e-c344-452d-acaa-512eb068ce17 61 fields · synced May 17, 2026
  • EUDAMED 12b7e5a9-9779-4b30-b4b6-3c6906b111d9 61 fields · synced May 17, 2026
  • EUDAMED 1d443df9-51da-4df1-8497-b19732eb716b 61 fields · synced May 17, 2026
  • EUDAMED 2f7b2945-9be3-48b6-8650-5935f671c84d 61 fields · synced May 17, 2026
  • EUDAMED 9d41a77d-27a7-4972-bfe3-95c68175e784 61 fields · synced May 17, 2026
  • EUDAMED 69636e1f-c8ac-4097-9190-368e0482d28c 61 fields · synced May 17, 2026
  • EUDAMED e295e893-366b-45ff-92df-e8c80277e1e5 61 fields · synced May 17, 2026
  • EUDAMED 5ba61081-f812-4124-8352-a94dae5ca273 61 fields · synced May 17, 2026
  • EUDAMED 9946193a-16ce-46f5-8222-33a83b85d7cb 61 fields · synced May 17, 2026
  • EUDAMED fa61575a-c7c9-4417-b967-13503bc32224 61 fields · synced May 17, 2026
  • EUDAMED f526b186-681b-4cd7-90ce-3c23f1ecf880 61 fields · synced May 17, 2026
  • EUDAMED 36f3c4a8-9852-4129-a218-99b091fbae37 61 fields · synced May 17, 2026
  • EUDAMED fc272af2-676f-4db2-a6e9-fff35969824a 61 fields · synced May 18, 2026
  • EUDAMED f50f7803-e60f-48c3-a0e9-38a699ec986b 61 fields · synced May 18, 2026
  • EUDAMED 335236ba-1622-4ea7-8580-fb66fb9ae5ce 61 fields · synced May 18, 2026
  • EUDAMED ddfb4c75-d6cc-4993-b6f4-57efb100075b 61 fields · synced May 18, 2026
  • EUDAMED de972bb5-d14a-4aee-ae11-c8eb7d57adb0 61 fields · synced May 18, 2026
  • EUDAMED 32b08773-a799-4ffb-a9c2-ea01df7fbc6d 61 fields · synced May 18, 2026
  • EUDAMED aca9eb0e-9e60-4822-a64d-54c714a830c6 61 fields · synced May 18, 2026
  • EUDAMED ae40dd87-afd0-44a4-9a0a-dfbb517006af 61 fields · synced May 18, 2026
  • EUDAMED a34fb28e-31da-4287-aa8d-651f7a75e519 61 fields · synced May 18, 2026
  • EUDAMED 19a07387-b1a3-4f13-b74c-2e32b8d63a4b 61 fields · synced May 18, 2026
  • EUDAMED 7c1282df-3fee-40eb-99a9-6926a98703fa 61 fields · synced May 18, 2026
  • EUDAMED dfd66306-bc4f-42ca-a350-35473770874b 61 fields · synced May 18, 2026
  • FDA UDI 397a25dc-d57c-41ca-89fe-916c32718aee 35 fields · synced May 30, 2026
  • EUDAMED c8d4f955-3aeb-46b5-a153-e82554a0b5c2 61 fields · synced Jul 8, 2026
  • EUDAMED 31b2d6f0-f325-4b9a-9ab1-23be748057ad 61 fields · synced Jul 8, 2026
  • EUDAMED 1a814ad2-cb32-4335-a700-d495e2b21056 61 fields · synced Jul 9, 2026
  • EUDAMED 99fed4fe-d011-46d6-b622-6f117ac34d68 61 fields · synced Jul 10, 2026
  • EUDAMED 6c38436c-c2b3-450b-9703-74947ce3f774 61 fields · synced Jul 11, 2026
  • EUDAMED b74ea31b-93e5-4afb-b2eb-2d3727a4feb2 61 fields · synced Jul 12, 2026
  • EUDAMED bf7fab05-0c74-4881-945f-b9a2db598efb 61 fields · synced Jul 12, 2026
  • EUDAMED 3f809ac6-c6ea-4e6c-8162-f56e1937b63d 61 fields · synced Jul 13, 2026
  • EUDAMED c8ce7678-80c6-4819-91c2-0341a7d84ca3 61 fields · synced Jul 13, 2026
  • EUDAMED 23bf2a30-2e60-4898-aa56-0ffcd65aea49 61 fields · synced Jul 13, 2026
  • EUDAMED 646dfa7c-1a71-45ae-97ab-16bd9fc4e167 61 fields · synced Jul 16, 2026
  • EUDAMED 20c38c48-93af-444f-b6ca-519197a98d82 61 fields · synced Jul 20, 2026
  • EUDAMED 8f3e091e-7046-4bc0-a64e-09f8d907b918 61 fields · synced Jul 21, 2026
  • EUDAMED 169e5505-76e0-499a-ac9b-c8f1cc178ff7 61 fields · synced Jul 21, 2026
  • EUDAMED 7d153594-8672-4c02-89e1-9db98635accd 61 fields · synced Jul 22, 2026
  • EUDAMED f09540cf-099a-45bf-a40e-b8a3cdbb3e87 61 fields · synced Jul 25, 2026
  • EUDAMED f3015908-3121-40c2-8d90-e43ca8189ca9 61 fields · synced Jul 26, 2026
  • EUDAMED 344374b9-6617-4cd2-a754-5f8a7760e805 61 fields · synced Jul 27, 2026
  • EUDAMED 4b96c979-3e1c-4889-a7a2-2349a44dab59 61 fields · synced Jul 29, 2026
  • EUDAMED e7cb8b03-db1e-46f9-8701-327a43133684 61 fields · synced Jul 29, 2026