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Sterile Acupuncture Needles
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref DX-4005Model 0.16x13mm
Identity
- Trade Name
- CARBO FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- Sterile Acupuncture Needles EUDAMEDDeluxe Series DX-Pack FDA UDI
- Model / Reference
- 0.16x13mm EUDAMEDDX-4005 EUDAMEDFDA UDI
- Description
- Deluxe Series DX-Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973169041532 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06973169041532 EUDAMED
- FDA Product Code
- MQX FDA UDI
- EMDN Code
- A019002 ACUPUNCTURE NEEDLES EUDAMED
- GMDN Term
- Acupuncture needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5580 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sterile Acupuncture Needles by Wujiang City Shen Ling Medical Device Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973169041532 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Wujiang City Shen Ling Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000021161
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 67a9513d-78cf-4ccf-95fe-621a9b831fad 61 fields · synced Jun 18, 2026
- FDA UDI 283e78b2-a587-41ff-9a15-64e7891efcd5 33 fields · synced May 29, 2026