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Betica
EUDAMEDClass IIa (EU MDR)
Ref SL-23-18TModel Type A, Type B, Type C, Type T, Type MRef IPN31*5Model IPN-32-4Ref SL-30-18TRef BL-28GRef IPN31*8Ref IPN32*6ETWRef IPN32*6Ref IPN31*6Ref IPN31*5QETWRef DPN-30*5Ref DPN-30*8Ref DPN-31*4Ref NPN-33*4Ref DPN-31*5Ref NPN-32*4Ref NPN-32*6
Identity
- Trade Name
- Betica EUDAMED
- Device Name
- Safety Blood Lancets EUDAMEDInsulin Pen Needles EUDAMEDBlood Lancets EUDAMEDsafety pen needle EUDAMED
- Model / Reference
- Type A, Type B, Type C, Type T, Type M EUDAMEDSL-23-18T EUDAMEDIPN-32-4 EUDAMEDIPN31*5 EUDAMEDSL-30-18T EUDAMEDBL-28G EUDAMEDIPN31*8 EUDAMEDIPN32*6ETW EUDAMEDIPN32*6 EUDAMEDIPN31*6 EUDAMEDIPN31*5QETW EUDAMEDDPN-30*5 EUDAMEDDPN-30*8 EUDAMEDDPN-31*4 EUDAMEDNPN-33*4 EUDAMEDDPN-31*5 EUDAMEDNPN-32*4 EUDAMEDNPN-32*6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978111923331 EUDAMED06978111923300 EUDAMED06978111923348 EUDAMED06971227407306 EUDAMED06971227403124 EUDAMED06971227407368 EUDAMED06971227407382 EUDAMED06978111923324 EUDAMED06978111925434 EUDAMED06971227407344 EUDAMED06971227407429 EUDAMED06978111923355 EUDAMED06971227407320 EUDAMED06971227409287 EUDAMED06975965295607 EUDAMED06971227407337 EUDAMED06971227404633 EUDAMED06978111923379 EUDAMED06978111923362 EUDAMED06971227407313 EUDAMED06978111923270 EUDAMED06978111923263 EUDAMED
- Basic UDI-DI
- 697122740SLYU EUDAMED697122740IPNPZ EUDAMED697122740BLX9 EUDAMED697122740SPNRK EUDAMED
- Unit of Use DI
- 86978111923337 EUDAMED86978111923306 EUDAMED86978111923344 EUDAMED86971227407302 EUDAMED86971227403120 EUDAMED86971227407364 EUDAMED86971227407388 EUDAMED86978111923320 EUDAMED86978111925430 EUDAMED86971227407340 EUDAMED86971227407425 EUDAMED86978111923351 EUDAMED86971227407326 EUDAMED86971227409283 EUDAMED86975965295603 EUDAMED86971227407333 EUDAMED86971227404639 EUDAMED86978111923375 EUDAMED86978111923368 EUDAMED86971227407319 EUDAMED16978111923277 EUDAMED86978111923269 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDA0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMEDV010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMEDA0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMEDGermany EUDAMEDNetherlands EUDAMEDBelgium 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
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Blood lancet, single-use
Betica by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697122740SLYU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008465
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (22)
- EUDAMED 2d66cd2c-47c1-483d-95dc-f3e76750d0cb 61 fields · synced Sep 18, 2026
- EUDAMED e8046e05-bf4e-4fc3-857b-6ab89825fb4e 61 fields · synced May 16, 2026
- EUDAMED 7f5fc64d-1a3a-428a-a60e-562fe78e76b6 61 fields · synced May 17, 2026
- EUDAMED bc1ef425-b5dd-4604-9d81-6a843ec1d64f 61 fields · synced May 17, 2026
- EUDAMED da9be11f-5d8e-48d0-8727-52fc3edc22ce 61 fields · synced May 17, 2026
- EUDAMED c5c059db-60db-4f78-bb18-b4ef845e8b45 61 fields · synced May 17, 2026
- EUDAMED c1ae60d0-38d2-420c-b9a0-b72c9bfa9f8a 61 fields · synced May 18, 2026
- EUDAMED 9656cc60-ae0f-4bea-b954-5b619da27037 61 fields · synced May 18, 2026
- EUDAMED 0e325228-5bc7-4cfc-b010-9fa9257ba17d 61 fields · synced May 19, 2026
- EUDAMED a79694af-0926-4e62-b862-994b46cbe619 61 fields · synced May 19, 2026
- EUDAMED 7f158c5d-e426-4a9d-a421-c81eb5947dba 61 fields · synced May 19, 2026
- EUDAMED cc7741c5-a2fa-4fe8-9ce9-993fa9010a6c 61 fields · synced Jul 10, 2026
- EUDAMED b3fc4171-c5f3-4fe4-8150-c78fd4ac99be 61 fields · synced Jul 10, 2026
- EUDAMED 225e0864-d593-4ed7-84de-649ba4acf5bb 61 fields · synced Jul 12, 2026
- EUDAMED 79ab0355-d81f-4338-8d80-1dea99cc9a77 61 fields · synced Jul 12, 2026
- EUDAMED 43a645df-4d81-4168-b1b4-f9cdf2ce64f5 61 fields · synced Jul 14, 2026
- EUDAMED f5088ac0-6a4d-4388-beba-5bf40bcd5515 61 fields · synced Jul 16, 2026
- EUDAMED 4764bbd8-c3a6-4820-a3ec-af939f5d9340 61 fields · synced Jul 18, 2026
- EUDAMED 41921510-b17a-4829-a8d4-4f747bc1511a 61 fields · synced Jul 30, 2026
- EUDAMED 41a0e6b3-167b-430a-b45c-b8a04382e7ff 61 fields · synced Jul 31, 2026
- EUDAMED 602d9d06-9efa-4c35-8f6a-3b3fe972e9cd 61 fields · synced Jul 31, 2026
- EUDAMED bd00532b-29b4-472c-905d-52217f5dfeb0 61 fields · synced Sep 17, 2026