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Safety syringe
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref SS0502112Ref SS0053058Ref SS0052858Ref SS0502101Ref SS0502412Ref SS0052301Ref SS0502215Ref SS1002201Ref SS0302715Ref SS0502605Ref SS1002705Ref SS0102658Ref SS1002158Ref SS0502405Ref SS0502558Ref SS1002258Ref SS0052605Ref SS1002505Ref SS0052901Ref SS1002112Ref SS1002658Ref SS0102615Ref SS0052512Ref SS0302312Ref SS0102715Ref SS0053015Ref SS0502401Ref SS0052515Ref SS0502615Ref SS0102612Ref SS0302601Ref SS0052758Ref SS0102458Ref SS0502301Ref SS0102605Ref SS0052958Ref SS1002458Ref SS0103015Ref SS0502512Ref SS0052612Ref SS0302758Ref SS0052505Ref SS0102515Ref SS0102758Ref SS0052401Ref SS0052701Ref SS0053005Ref SS0302358Ref SS0102312Ref SS1002501Ref SS0302112
Identity
- Trade Name
- Safety syringe EUDAMED
- Device Name
- Safety syringe EUDAMED
- Model / Reference
- SS0502112 EUDAMEDSS0053058 EUDAMEDSS0052858 EUDAMEDSS0502101 EUDAMEDSS0502412 EUDAMEDSS0052301 EUDAMEDSS0502215 EUDAMEDSS1002201 EUDAMEDSS0302715 EUDAMEDSS0502605 EUDAMEDSS1002705 EUDAMEDSS0102658 EUDAMEDSS1002158 EUDAMEDSS0502405 EUDAMEDSS0502558 EUDAMEDSS1002258 EUDAMEDSS0052605 EUDAMEDSS1002505 EUDAMEDSS0052901 EUDAMEDSS1002112 EUDAMEDSS1002658 EUDAMEDSS0102615 EUDAMEDSS0052512 EUDAMEDSS0302312 EUDAMEDSS0102715 EUDAMEDSS0053015 EUDAMEDSS0502401 EUDAMEDSS0052515 EUDAMEDSS0502615 EUDAMEDSS0102612 EUDAMEDSS0302601 EUDAMEDSS0052758 EUDAMEDSS0102458 EUDAMEDSS0502301 EUDAMEDSS0102605 EUDAMEDSS0052958 EUDAMEDSS1002458 EUDAMEDSS0103015 EUDAMEDSS0502512 EUDAMEDSS0052612 EUDAMEDSS0302758 EUDAMEDSS0052505 EUDAMEDSS0102515 EUDAMEDSS0102758 EUDAMEDSS0052401 EUDAMEDSS0052701 EUDAMEDSS0053005 EUDAMEDSS0302358 EUDAMEDSS0102312 EUDAMEDSS1002501 EUDAMEDSS0302112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972769413220 EUDAMED06972769411981 EUDAMED06972769411929 EUDAMED06972769412285 EUDAMED06972769413305 EUDAMED06972769412872 EUDAMED06972769412322 EUDAMED06972769412070 EUDAMED06972769411806 EUDAMED06972769413336 EUDAMED06972769413190 EUDAMED06972769411479 EUDAMED06972769412049 EUDAMED06972769413299 EUDAMED06972769412377 EUDAMED06972769412063 EUDAMED06972769412964 EUDAMED06972769413152 EUDAMED06972769411967 EUDAMED06972769413084 EUDAMED06972769412186 EUDAMED06972769411493 EUDAMED06972769412957 EUDAMED06972769412742 EUDAMED06972769411523 EUDAMED06972769412001 EUDAMED06972769412353 EUDAMED06972769411851 EUDAMED06972769412421 EUDAMED06972769412582 EUDAMED06972769411769 EUDAMED06972769411899 EUDAMED06972769411448 EUDAMED06972769413268 EUDAMED06972769412575 EUDAMED06972769411950 EUDAMED06972769412124 EUDAMED06972769411615 EUDAMED06972769413329 EUDAMED06972769412971 EUDAMED06972769411783 EUDAMED06972769412926 EUDAMED06972769412568 EUDAMED06972769411509 EUDAMED06972769411837 EUDAMED06972769411905 EUDAMED06972769413046 EUDAMED06972769412728 EUDAMED06972769412483 EUDAMED06972769412162 EUDAMED06972769412681 EUDAMED
- Basic UDI-DI
- 697276941DR002SSP9 EUDAMED
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Safety syringe by Zhuhai DR Medical Instruments Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212226 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697276941DR002SSP9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhuhai DR Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000021135
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (52)
- EUDAMED 2849fcbe-5324-4f5d-845a-9cf7f488ec6b 61 fields · synced Oct 6, 2026
- EUDAMED 93531174-b344-4313-b9f8-37e86bfcf9f7 61 fields · synced May 11, 2026
- EUDAMED 175696df-552a-414e-8461-75a4a7e7bc3b 61 fields · synced May 11, 2026
- EUDAMED 186e16c3-6346-4d6b-aecf-136c97d89774 61 fields · synced May 11, 2026
- EUDAMED 767575c3-f380-4d8c-9b2d-c9020439eab3 61 fields · synced May 16, 2026
- EUDAMED f6b3cbfe-f86f-41d2-a0f7-eded9e39d15b 61 fields · synced May 16, 2026
- EUDAMED 719a69ac-768b-4057-857a-a833b1228127 61 fields · synced May 16, 2026
- EUDAMED bf20b9fa-74c4-48bc-b520-0adce062de25 61 fields · synced May 16, 2026
- EUDAMED fd0827b0-4b55-43a6-98d4-1afa9bee49b1 61 fields · synced May 16, 2026
- EUDAMED 2ef15176-bd2c-4f3a-98ee-d8f14760a797 61 fields · synced May 16, 2026
- EUDAMED b7a9435b-15c9-4eac-b10a-358388e6b6b8 61 fields · synced May 16, 2026
- EUDAMED 77366296-da75-4d02-8a91-2252e18c613b 61 fields · synced May 16, 2026
- EUDAMED 2baa1de7-3b2f-4d37-8faf-1c7fd2e43780 61 fields · synced May 17, 2026
- EUDAMED 5ecb6aba-e622-46bb-b5a0-ad0fb011d317 61 fields · synced May 17, 2026
- EUDAMED 99a3c36e-8c41-455b-a11c-1e2dd6eb8157 61 fields · synced May 17, 2026
- EUDAMED 94e81c66-5b58-43fc-8f04-7bedb22fb41a 61 fields · synced May 17, 2026
- EUDAMED cf8c8f00-5f2b-4854-b006-1175be9145ae 61 fields · synced May 17, 2026
- EUDAMED 9089f347-6f62-4df0-a712-33fc2d0b5568 61 fields · synced May 17, 2026
- EUDAMED 9ec05765-0b50-4023-9526-5410836b2714 61 fields · synced May 17, 2026
- EUDAMED 35c84c32-edc7-40c2-b4af-98f2cf8b2969 61 fields · synced May 17, 2026
- EUDAMED 9cde6bb6-c3e8-41da-9981-d3747e9534e7 61 fields · synced May 17, 2026
- EUDAMED 4462e085-f5c6-46cd-85f0-aa21d1309a36 61 fields · synced May 17, 2026
- EUDAMED 022d5c34-0345-4c80-97de-6d51f47299b9 61 fields · synced May 17, 2026
- EUDAMED b41b5727-6f4f-4f68-b62c-f27454764e2c 61 fields · synced May 17, 2026
- EUDAMED 88eecedb-143e-4448-93e6-7e4786b4d7c6 61 fields · synced May 17, 2026
- EUDAMED c42cb9af-f2f3-4000-bd9b-e0ce829e1aba 61 fields · synced May 17, 2026
- EUDAMED 28b52ce6-f8fa-4295-bb10-5d89ee2a1467 61 fields · synced May 17, 2026
- EUDAMED 535cd9d5-2e42-49ee-8f0b-810fe9539212 61 fields · synced May 17, 2026
- EUDAMED 9ecb0d73-3558-489c-b315-4bca04d4dbcc 61 fields · synced May 17, 2026
- EUDAMED 45632568-ae50-46a9-8eaa-5c9c174051ea 61 fields · synced May 17, 2026
- EUDAMED 9494b563-168f-408b-9c8f-5535621fab16 61 fields · synced May 17, 2026
- EUDAMED 6edf8316-69cf-4765-93e3-c393a37c1fed 61 fields · synced May 17, 2026
- EUDAMED facdee11-95f5-4483-b883-47424e2ba8a0 61 fields · synced May 17, 2026
- EUDAMED ef425c76-38e2-492d-9dfb-4683901ea9da 61 fields · synced May 17, 2026
- EUDAMED ccc6c717-a966-4d7a-8b48-68b7b14c0998 61 fields · synced May 17, 2026
- EUDAMED d3e8e40a-2579-406f-8d25-1a93bc29dc2c 61 fields · synced May 17, 2026
- EUDAMED 64fbbf5b-7bbe-4aa1-82e2-f763856ed0f1 61 fields · synced May 17, 2026
- EUDAMED 22332a92-aa6a-474a-be28-11d88e7213ad 61 fields · synced May 17, 2026
- EUDAMED 5190e196-494f-4b82-9ab5-592d78f9d596 61 fields · synced May 17, 2026
- EUDAMED dc183ff9-ced3-4d3e-8ad3-b395691ede9d 61 fields · synced May 17, 2026
- EUDAMED 3d5f36b0-188f-4d8c-bf20-17953f76511a 61 fields · synced May 17, 2026
- EUDAMED 900c282e-d2af-42b1-b239-3e83b17aafbc 61 fields · synced May 17, 2026
- EUDAMED 7fbcae04-6731-4f6c-9f3a-4df9d939b73d 61 fields · synced May 17, 2026
- EUDAMED 33971665-ac36-4207-a179-f60165502efa 61 fields · synced May 17, 2026
- EUDAMED 3fdf4a1c-279e-4b61-94b7-e685989bb5d1 61 fields · synced May 17, 2026
- EUDAMED 82829aa2-dd09-4e5b-a62b-0da280fd90ed 61 fields · synced May 17, 2026
- EUDAMED 2a89f412-85d4-4e16-810b-8b964ef1b7b5 61 fields · synced May 17, 2026
- EUDAMED b81ae17e-ecf9-479c-981d-7eadf8702294 61 fields · synced May 17, 2026
- EUDAMED 8e008f62-cde4-422e-9e8d-73b3cd95c3b8 61 fields · synced May 17, 2026
- EUDAMED 9a55035d-115b-485c-b63e-1f2d55ef53e5 61 fields · synced May 17, 2026
- EUDAMED cc7122d6-9d28-4040-a7b7-b44bd8ceabb0 61 fields · synced May 17, 2026
- FDA 510(k) K212226 1 fields · synced May 18, 2026