← Back to catalogue
Sterile Surgical Packs
EUDAMEDClass I (EU MDR)
Ref 70-1100-SAModel Universal Set Reinforced; Universal Slit Sheet Set; Minor Surgery Set Up Set; Minor Surgery Set; Craniotomy Drape Set; Laparotomy/Chest Set; Laparotomy/Chest Pack; Rectum Set; Universal Self-Adhesive Reinforced Set; Angiography Set; CABG Pack; etc. Ref 70-1001-SERef 70-2001-SRef 70-5022-SRef 70-3030-STRef 70-6000-SRef 70-3005-SERef 70-2000-STRef 70-3135-SERef 70-7000-SRef 70-3001-SRef 70-5012-STRef 70-5011-SRef 70-3020-SERef 70-5010-SRef 70-1001-SRef 70-1033-SRef 70-8000-SERef 70-1101-SARef 70-5021-STRef 70-6110-SARef 70-1005-SERef 70-3030-SRef 70-3002-SRef 70-5001-SRef 70-3002-STRef 70-2010-SRef 70-3031-SERef 70-5013-SERef 70-3001-STRef 70-1133-SARef 70-2000-SRef 70-6002-SERef 70-5030-SRef 70-3040-SRef 70-7013-SERef 70-1000-SRef 70-1032-SRef 70-1120-SERef 70-1040-SRef 70-2020-SRef 70-2010-STRef 70-1004-SERef 70-1031-STRef 70-1012-SRef 70-7010-SRef 70-5011-STRef 70-3040-STRef 70-6011-SERef 70-3031-ST
Identity
- Trade Name
- Sterile Surgical Packs EUDAMED
- Device Name
- Sterile Surgical Packs EUDAMED
- Model / Reference
- Universal Set Reinforced; Universal Slit Sheet Set; Minor Surgery Set Up Set; Minor Surgery Set; Craniotomy Drape Set; Laparotomy/Chest Set; Laparotomy/Chest Pack; Rectum Set; Universal Self-Adhesive Reinforced Set; Angiography Set; CABG Pack; etc. EUDAMED70-1100-SA EUDAMED70-1001-SE EUDAMED70-2001-S EUDAMED70-5022-S EUDAMED70-3030-ST EUDAMED70-6000-S EUDAMED70-3005-SE EUDAMED70-2000-ST EUDAMED70-3135-SE EUDAMED70-7000-S EUDAMED70-3001-S EUDAMED70-5012-ST EUDAMED70-5011-S EUDAMED70-3020-SE EUDAMED70-5010-S EUDAMED70-1001-S EUDAMED70-1033-S EUDAMED70-8000-SE EUDAMED70-1101-SA EUDAMED70-5021-ST EUDAMED70-6110-SA EUDAMED70-1005-SE EUDAMED70-3030-S EUDAMED70-3002-S EUDAMED70-5001-S EUDAMED70-3002-ST EUDAMED70-2010-S EUDAMED70-3031-SE EUDAMED70-5013-SE EUDAMED70-3001-ST EUDAMED70-1133-SA EUDAMED70-2000-S EUDAMED70-6002-SE EUDAMED70-5030-S EUDAMED70-3040-S EUDAMED70-7013-SE EUDAMED70-1000-S EUDAMED70-1032-S EUDAMED70-1120-SE EUDAMED70-1040-S EUDAMED70-2020-S EUDAMED70-2010-ST EUDAMED70-1004-SE EUDAMED70-1031-ST EUDAMED70-1012-S EUDAMED70-7010-S EUDAMED70-5011-ST EUDAMED70-3040-ST EUDAMED70-6011-SE EUDAMED70-3031-ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04895237164238 EUDAMED04895237164030 EUDAMED04895237164290 EUDAMED04895237164672 EUDAMED04895237164467 EUDAMED04895237164702 EUDAMED04895237137485 EUDAMED04895237164283 EUDAMED04895237164511 EUDAMED04895237164757 EUDAMED04895237164368 EUDAMED04895237164603 EUDAMED04895237164573 EUDAMED04895237164436 EUDAMED04895237164566 EUDAMED04895237164023 EUDAMED04895237164184 EUDAMED04895237164801 EUDAMED04895237164245 EUDAMED04895237164665 EUDAMED04895237135283 EUDAMED04895237164078 EUDAMED04895237164450 EUDAMED04895237164382 EUDAMED04895237164559 EUDAMED04895237164399 EUDAMED04895237164313 EUDAMED04895237164474 EUDAMED04895237164610 EUDAMED04895237164375 EUDAMED04895237164269 EUDAMED04895237164276 EUDAMED04895237164726 EUDAMED04895237134477 EUDAMED04895237164498 EUDAMED04895237164788 EUDAMED04895237164016 EUDAMED04895237164177 EUDAMED04895237164252 EUDAMED04895237164221 EUDAMED04895237164337 EUDAMED04895237164320 EUDAMED04895237164061 EUDAMED04895237164160 EUDAMED04895237164108 EUDAMED04895237164764 EUDAMED04895237164580 EUDAMED04895237164504 EUDAMED04895237164740 EUDAMED04895237164481 EUDAMED
- Basic UDI-DI
- 48952371004UX EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Surgical Packs by Kenpax International Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 48952371004UX | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kenpax International Limited
- EUDAMED SRN
- HK-MF-000021152
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (50)
- EUDAMED 1abe8c89-6527-4f46-a4ab-c2297e24761d 61 fields · synced Sep 18, 2026
- EUDAMED 15a3f852-19ad-49bd-98b8-6e9725c8035c 61 fields · synced May 11, 2026
- EUDAMED 67591541-e4c2-4e99-a98b-21c55c936d8b 61 fields · synced May 16, 2026
- EUDAMED c1555b96-8da5-4706-b8ca-e2062dbfcd6c 61 fields · synced May 16, 2026
- EUDAMED 60aebcc6-5548-47aa-bae7-7d8b70d6feda 61 fields · synced May 16, 2026
- EUDAMED 4d4b578d-6984-42ca-89db-449a23d32a87 61 fields · synced May 16, 2026
- EUDAMED 3dac6ddb-5763-46f5-861f-a903586ea267 61 fields · synced May 16, 2026
- EUDAMED c9a37e6b-376a-4129-9eb8-ad7b2ea1784b 61 fields · synced May 17, 2026
- EUDAMED c2bb7bf8-bcd3-45f1-b609-61259557a1e5 61 fields · synced May 17, 2026
- EUDAMED 5af84682-c878-441b-bc15-29b765a99bc5 61 fields · synced May 17, 2026
- EUDAMED 22d56cb9-c192-40e4-a828-c1339128b70b 61 fields · synced May 17, 2026
- EUDAMED d0a1d398-7d6c-465b-b94b-ff5d308039aa 61 fields · synced May 17, 2026
- EUDAMED b051598e-6597-4dc2-914f-1a21d5f31f48 61 fields · synced May 17, 2026
- EUDAMED 080781cd-6e3e-4aef-9fe5-a4987675f0d8 61 fields · synced May 17, 2026
- EUDAMED 93675ba2-339f-4ba6-ae41-8390e3330a1a 61 fields · synced May 17, 2026
- EUDAMED 0f8f4be3-1335-4207-8a78-2a8cb20b0fb0 61 fields · synced May 17, 2026
- EUDAMED c8cc92a9-c0d1-4c7b-b97b-39ddc0baaa6d 61 fields · synced May 17, 2026
- EUDAMED c657b380-4f31-4194-af9b-b145f6eac8a8 61 fields · synced May 17, 2026
- EUDAMED f2c559ce-e81e-449a-9e04-f63ce1be482f 61 fields · synced May 17, 2026
- EUDAMED 35ec0563-dc2e-4985-955a-5f6b7e99b047 61 fields · synced May 17, 2026
- EUDAMED fccc429a-fd0f-4e6a-a4a2-a2952be5802e 61 fields · synced May 17, 2026
- EUDAMED ff34ba5e-6c06-4751-b0af-4f683f4cfa97 61 fields · synced May 17, 2026
- EUDAMED 60982abb-66a8-44d0-809c-93fb73f0f24d 61 fields · synced May 17, 2026
- EUDAMED 71e7c0a1-0482-466a-a643-a2adbf264970 61 fields · synced May 18, 2026
- EUDAMED e9e03ce9-06ce-4bd0-a43f-9f474993f6f5 61 fields · synced May 18, 2026
- EUDAMED e8bf4222-7adc-497a-a38d-ebb73b6d69f7 61 fields · synced May 18, 2026
- EUDAMED 2b0c07f2-4b77-499e-841d-a0a15c2d7714 61 fields · synced May 18, 2026
- EUDAMED 5c8c96fb-69cb-4eb8-9eb2-2762abef2af0 61 fields · synced May 18, 2026
- EUDAMED 1085eced-57ab-4568-a508-39dd875111b6 61 fields · synced May 18, 2026
- EUDAMED 12fd5605-0c13-4a6d-bcdc-a70e00008002 61 fields · synced May 18, 2026
- EUDAMED 795de827-603b-44a4-bf0e-c6d0ec0a60c9 61 fields · synced May 18, 2026
- EUDAMED 01e534a4-0843-4c89-ae8c-18c5a1a1dced 61 fields · synced May 18, 2026
- EUDAMED 6747cc49-d4af-4191-af42-125ef3eaaaa6 61 fields · synced May 18, 2026
- EUDAMED 9c6169c2-c079-47a6-91fd-0e5bbaa0f844 61 fields · synced May 18, 2026
- EUDAMED a4c678d1-ce43-4cd6-922f-cea19640ea4a 61 fields · synced May 18, 2026
- EUDAMED 3e5a3081-29d6-4a55-9c6b-a1b05cf0e655 61 fields · synced May 18, 2026
- EUDAMED 80452670-196d-40fc-8e8c-bfd9b9eb6036 61 fields · synced May 18, 2026
- EUDAMED 00080bd7-2ae8-4f65-9cfc-c13a13a3c3cd 61 fields · synced May 18, 2026
- EUDAMED 321fc974-b1d6-431c-8f02-801a52aba236 61 fields · synced May 18, 2026
- EUDAMED 5c15cf37-16de-4bed-ae20-3411929ba12c 61 fields · synced May 18, 2026
- EUDAMED 13651f13-5368-45c2-852c-faf3c60d7a9d 61 fields · synced May 18, 2026
- EUDAMED 94b80b32-be82-44a3-b583-6d48de48908c 61 fields · synced May 18, 2026
- EUDAMED bdad48a4-5457-45df-a158-7966dde956d8 61 fields · synced May 18, 2026
- EUDAMED 018c0d31-3730-4eee-830b-bfc8964b1971 61 fields · synced May 18, 2026
- EUDAMED 101e8048-6dbe-4e3a-8bfe-c65c96737f0c 61 fields · synced May 18, 2026
- EUDAMED b7eee027-5f9d-461c-9722-0ac1e6774dab 61 fields · synced May 18, 2026
- EUDAMED 67252199-b8d7-44e2-ab49-ed8ea2767005 61 fields · synced May 18, 2026
- EUDAMED 07128ba0-8dd6-4382-bd17-a0226f21b891 61 fields · synced May 19, 2026
- EUDAMED 432351c8-82a8-4a42-a2bc-e0d8fa1be335 61 fields · synced May 19, 2026
- EUDAMED 2ea31a15-3718-44a2-ace7-971b297a273d 61 fields · synced May 19, 2026